{
"NDC": [
{
"NDCCode": "55312-000-56",
"PackageDescription": "226 g in 1 BOTTLE, PLASTIC (55312-000-56)",
"NDC11Code": "55312-0000-56",
"ProductNDC": "55312-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Western Family Broad Spectrum Sunscreen",
"ProprietaryNameSuffix": "Spf 70",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140303",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "WESTERN FAMILY FOODS, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 15; 5; 10; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures( see directions) , decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "55312-005-56",
"PackageDescription": "226 g in 1 BOTTLE, PLASTIC (55312-005-56)",
"NDC11Code": "55312-0005-56",
"ProductNDC": "55312-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Western Family Sport Sunscreen",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140702",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "WESTERN FAMILY FOODS, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10; 5; 4; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "55312-886-56",
"PackageDescription": "1 KIT in 1 CARTON (55312-886-56) * 6 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK * 4 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55312-0886-56",
"ProductNDC": "55312-886",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Relief",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20110922",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Western Family Foods Inc",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "41250-000-56",
"PackageDescription": "226 g in 1 BOTTLE (41250-000-56)",
"NDC11Code": "41250-0000-56",
"ProductNDC": "41250-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10; 5; 4; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "54162-000-02",
"PackageDescription": "56 g in 1 TUBE (54162-000-02) ",
"NDC11Code": "54162-0000-02",
"ProductNDC": "54162-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitamin A And D",
"NonProprietaryName": "Vitamin A And D",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "GERITREX LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "30.8",
"StrengthUnit": "g/56g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary protection of minor cuts, scrapes, burns. Protects chafed skin."
},
{
"NDCCode": "59428-000-56",
"PackageDescription": "1 TUBE in 1 CARTON (59428-000-56) > 56 g in 1 TUBE",
"NDC11Code": "59428-0000-56",
"ProductNDC": "59428-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quadrydern",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Productos Zapotol Corp",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130630",
"SamplePackage": "N"
},
{
"NDCCode": "82167-000-09",
"PackageDescription": ".56 mL in 1 PATCH (82167-000-09) ",
"NDC11Code": "82167-0000-09",
"ProductNDC": "82167-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tinfu Isopropyl Alcohol Prep Pads",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shandong T&F Medical Technology Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to injection."
},
{
"NDCCode": "82167-000-10",
"PackageDescription": "100 PACKET in 1 BOX (82167-000-10) / .56 mL in 1 PACKET",
"NDC11Code": "82167-0000-10",
"ProductNDC": "82167-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tinfu Isopropyl Alcohol Prep Pads",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shandong T&F Medical Technology Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to injection."
},
{
"NDCCode": "82167-000-11",
"PackageDescription": "200 PACKET in 1 BOX (82167-000-11) / .56 mL in 1 PACKET",
"NDC11Code": "82167-0000-11",
"ProductNDC": "82167-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tinfu Isopropyl Alcohol Prep Pads",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shandong T&F Medical Technology Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to injection."
},
{
"NDCCode": "82167-000-12",
"PackageDescription": "300 PACKET in 1 BOX (82167-000-12) / .56 mL in 1 PACKET",
"NDC11Code": "82167-0000-12",
"ProductNDC": "82167-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tinfu Isopropyl Alcohol Prep Pads",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shandong T&F Medical Technology Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to injection."
},
{
"NDCCode": "0032-1206-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE",
"NDC11Code": "00032-1206-56",
"ProductNDC": "0032-1206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "30000; 6000; 19000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "Y",
"IndicationAndUsage": "CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0440-2055-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (0440-2055-40)",
"NDC11Code": "00440-2055-40",
"ProductNDC": "0440-2055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "0440-8055-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (0440-8055-40)",
"NDC11Code": "00440-8055-40",
"ProductNDC": "0440-8055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "0440-8056-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (0440-8056-40)",
"NDC11Code": "00440-8056-40",
"ProductNDC": "0440-8056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "0781-3485-95",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) ",
"NDC11Code": "00781-3485-95",
"ProductNDC": "0781-3485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "10544-296-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (10544-296-20)",
"NDC11Code": "10544-0296-20",
"ProductNDC": "10544-296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "10544-296-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (10544-296-28)",
"NDC11Code": "10544-0296-28",
"ProductNDC": "10544-296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "10544-296-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (10544-296-40)",
"NDC11Code": "10544-0296-40",
"ProductNDC": "10544-296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "10544-297-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (10544-297-20)",
"NDC11Code": "10544-0297-20",
"ProductNDC": "10544-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "10544-297-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (10544-297-28)",
"NDC11Code": "10544-0297-28",
"ProductNDC": "10544-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "10544-297-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-297-30)",
"NDC11Code": "10544-0297-30",
"ProductNDC": "10544-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "10544-297-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (10544-297-40)",
"NDC11Code": "10544-0297-40",
"ProductNDC": "10544-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "17224-322-56",
"PackageDescription": "56 TABLET, COATED in 1 BOTTLE (17224-322-56) ",
"NDC11Code": "17224-0322-56",
"ProductNDC": "17224-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"EndMarketingDate": "20250826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "Calvin Scott & Co., Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190501",
"EndMarketingDatePackage": "20250826",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "33261-134-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-134-30)",
"NDC11Code": "33261-0134-30",
"ProductNDC": "33261-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "33261-134-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (33261-134-40)",
"NDC11Code": "33261-0134-40",
"ProductNDC": "33261-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062936",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "33261-138-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (33261-138-20)",
"NDC11Code": "33261-0138-20",
"ProductNDC": "33261-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "33261-138-28",
"PackageDescription": "28 TABLET in 1 BOTTLE, PLASTIC (33261-138-28)",
"NDC11Code": "33261-0138-28",
"ProductNDC": "33261-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "33261-138-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-138-30)",
"NDC11Code": "33261-0138-30",
"ProductNDC": "33261-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "33261-138-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (33261-138-40)",
"NDC11Code": "33261-0138-40",
"ProductNDC": "33261-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF."
},
{
"NDCCode": "33342-295-56",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-295-56) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0295-56",
"ProductNDC": "33342-295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207796",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "CHOLINE FENOFIBRATE",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240226",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibric acid delayed-release capsules is indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.Limitations of Use Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].",
"Description": "Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed-release capsules for oral administration. Each delayed-release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1). with the following structural formula:. The molecular formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions. Each delayed-release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl methyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc and triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: FD&C Blue #2, iron oxide yellow, sodium lauryl sulfate and gelatin, titanium dioxide."
}
]
}
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<NDC11Code>55312-0886-56</NDC11Code>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 10; 5; 4; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54162-000-02</NDCCode>
<PackageDescription>56 g in 1 TUBE (54162-000-02) </PackageDescription>
<NDC11Code>54162-0000-02</NDC11Code>
<ProductNDC>54162-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitamin A And D</ProprietaryName>
<NonProprietaryName>Vitamin A And D</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>GERITREX LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>30.8</StrengthNumber>
<StrengthUnit>g/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary protection of minor cuts, scrapes, burns. Protects chafed skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59428-000-56</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59428-000-56) > 56 g in 1 TUBE</PackageDescription>
<NDC11Code>59428-0000-56</NDC11Code>
<ProductNDC>59428-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quadrydern</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Productos Zapotol Corp</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>82167-000-09</NDCCode>
<PackageDescription>.56 mL in 1 PATCH (82167-000-09) </PackageDescription>
<NDC11Code>82167-0000-09</NDC11Code>
<ProductNDC>82167-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tinfu Isopropyl Alcohol Prep Pads</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shandong T&F Medical Technology Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82167-000-10</NDCCode>
<PackageDescription>100 PACKET in 1 BOX (82167-000-10) / .56 mL in 1 PACKET</PackageDescription>
<NDC11Code>82167-0000-10</NDC11Code>
<ProductNDC>82167-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tinfu Isopropyl Alcohol Prep Pads</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shandong T&F Medical Technology Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82167-000-11</NDCCode>
<PackageDescription>200 PACKET in 1 BOX (82167-000-11) / .56 mL in 1 PACKET</PackageDescription>
<NDC11Code>82167-0000-11</NDC11Code>
<ProductNDC>82167-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tinfu Isopropyl Alcohol Prep Pads</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shandong T&F Medical Technology Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82167-000-12</NDCCode>
<PackageDescription>300 PACKET in 1 BOX (82167-000-12) / .56 mL in 1 PACKET</PackageDescription>
<NDC11Code>82167-0000-12</NDC11Code>
<ProductNDC>82167-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tinfu Isopropyl Alcohol Prep Pads</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shandong T&F Medical Technology Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0032-1206-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>00032-1206-56</NDC11Code>
<ProductNDC>0032-1206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>30000; 6000; 19000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090430</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0440-2055-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (0440-2055-40)</PackageDescription>
<NDC11Code>00440-2055-40</NDC11Code>
<ProductNDC>0440-2055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062936</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>0440-8055-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (0440-8055-40)</PackageDescription>
<NDC11Code>00440-8055-40</NDC11Code>
<ProductNDC>0440-8055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062936</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>0440-8056-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (0440-8056-40)</PackageDescription>
<NDC11Code>00440-8056-40</NDC11Code>
<ProductNDC>0440-8056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062935</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>0781-3485-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) </PackageDescription>
<NDC11Code>00781-3485-95</NDC11Code>
<ProductNDC>0781-3485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>10544-296-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (10544-296-20)</PackageDescription>
<NDC11Code>10544-0296-20</NDC11Code>
<ProductNDC>10544-296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062936</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>10544-296-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (10544-296-28)</PackageDescription>
<NDC11Code>10544-0296-28</NDC11Code>
<ProductNDC>10544-296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062936</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>10544-296-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (10544-296-40)</PackageDescription>
<NDC11Code>10544-0296-40</NDC11Code>
<ProductNDC>10544-296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062936</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>10544-297-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (10544-297-20)</PackageDescription>
<NDC11Code>10544-0297-20</NDC11Code>
<ProductNDC>10544-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062935</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
</NDC>
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<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C 16H 17KN 2O 5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
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<NDCCode>33342-295-56</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-295-56) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0295-56</NDC11Code>
<ProductNDC>33342-295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207796</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>CHOLINE FENOFIBRATE</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240226</StartMarketingDatePackage>
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<IndicationAndUsage>Fenofibric acid delayed-release capsules is indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.Limitations of Use Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed-release capsules for oral administration. Each delayed-release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1). with the following structural formula:. The molecular formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions. Each delayed-release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl methyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc and triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: FD&C Blue #2, iron oxide yellow, sodium lauryl sulfate and gelatin, titanium dioxide.</Description>
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