{
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"StrengthUnit": "mg/1",
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"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
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{
"NDCCode": "65197-296-08",
"PackageDescription": "1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN OTC DRUG",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-12",
"PackageDescription": "1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "65197-0296-12",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-16",
"PackageDescription": "2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0296-16",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-24",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0296-24",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230501",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "30142-296-32",
"PackageDescription": "370 mL in 1 BOTTLE, PLASTIC (30142-296-32) ",
"NDC11Code": "30142-0296-32",
"ProductNDC": "30142-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "The Kroger Co.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "37808-296-32",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (37808-296-32) ",
"NDC11Code": "37808-0296-32",
"ProductNDC": "37808-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090515",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "H E B",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090515",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "41163-296-32",
"PackageDescription": "370 mL in 1 BOTTLE, PLASTIC (41163-296-32) ",
"NDC11Code": "41163-0296-32",
"ProductNDC": "41163-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150119",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150119",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "59779-296-32",
"PackageDescription": "370 mL in 1 BOTTLE, PLASTIC (59779-296-32) ",
"NDC11Code": "59779-0296-32",
"ProductNDC": "59779-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence flaking and itching associated with dandruff."
},
{
"NDCCode": "63941-296-32",
"PackageDescription": "370 mL in 1 BOTTLE, PLASTIC (63941-296-32) ",
"NDC11Code": "63941-0296-32",
"ProductNDC": "63941-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231002",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Valu Merchandisers Company",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent recurrence flaking and itching associated with dandruff."
},
{
"NDCCode": "72476-296-32",
"PackageDescription": "370 mL in 1 BOTTLE, PLASTIC (72476-296-32) ",
"NDC11Code": "72476-0296-32",
"ProductNDC": "72476-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Retail Business Services, LLC",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231102",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "0378-3340-32",
"PackageDescription": "1 POUCH in 1 CARTON (0378-3340-32) > 1 PATCH in 1 POUCH (0378-3340-17) > 7 d in 1 PATCH",
"NDC11Code": "00378-3340-32",
"ProductNDC": "0378-3340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xulane",
"NonProprietaryName": "Norelgestromin And Ethinyl Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20140416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200910",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; NORELGESTROMIN",
"StrengthNumber": "35; 150",
"StrengthUnit": "ug/d; ug/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160613",
"SamplePackage": "Y",
"IndicationAndUsage": "Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use:. Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].",
"Description": "Xulane is a transdermal system with a contact surface area of 14 cm². It contains 4.86 mg norelgestromin, USP (NGMN) and 0.53 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN and 35 mcg of EE per day. Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [Css]) of NGMN and EE during use of norelgestromin and ethinyl estradiol transdermal system are higher and the Cmax is lower than those produced by an oral contraceptive containing NGM 250 mcg / EE 35 mcg. [See Boxed Warning and Clinical Pharmacology (12.3).]. Xulane is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a peach flexible film consisting of a pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutene adhesive, crospovidone, mineral oil, non-woven polyester fabric, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN and EE. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyester film with a fluoropolymer coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Xulane® (norelgestromin and ethinyl estradiol) 150/35 mcg per day” in brown ink. Xulane transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These pieces of protective film are removed and discarded at the time of use. The structural formulas of the components are. Molecular weight, NGMN: 327.47. Molecular weight, EE: 296.41. Chemical name for NGMN: 18, 19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-, 17-hydroxy, 3-oxime, (17α)-. Chemical name for EE: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17β-diol, (17α)-."
},
{
"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."
},
{
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"ProductNDC": "13668-538",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
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"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211227",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
},
{
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"ProductNDC": "13668-538",
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"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
},
{
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"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "200",
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"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
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"ProductNDC": "13668-539",
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"LabelerName": "Torrent Pharmaceuticals Limited",
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
},
{
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
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"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
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"ProductNDC": "13668-540",
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"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
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"StrengthUnit": "mg/1",
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<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63941-296-32</NDCCode>
<PackageDescription>370 mL in 1 BOTTLE, PLASTIC (63941-296-32) </PackageDescription>
<NDC11Code>63941-0296-32</NDC11Code>
<ProductNDC>63941-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dry Scalp Care</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231002</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Valu Merchandisers Company</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent recurrence flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72476-296-32</NDCCode>
<PackageDescription>370 mL in 1 BOTTLE, PLASTIC (72476-296-32) </PackageDescription>
<NDC11Code>72476-0296-32</NDC11Code>
<ProductNDC>72476-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dry Scalp Care</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Retail Business Services, LLC</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-3340-32</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0378-3340-32) > 1 PATCH in 1 POUCH (0378-3340-17) > 7 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-3340-32</NDC11Code>
<ProductNDC>0378-3340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xulane</ProprietaryName>
<NonProprietaryName>Norelgestromin And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20140416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200910</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; NORELGESTROMIN</SubstanceName>
<StrengthNumber>35; 150</StrengthNumber>
<StrengthUnit>ug/d; ug/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160613</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use:. Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Xulane is a transdermal system with a contact surface area of 14 cm². It contains 4.86 mg norelgestromin, USP (NGMN) and 0.53 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN and 35 mcg of EE per day. Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [Css]) of NGMN and EE during use of norelgestromin and ethinyl estradiol transdermal system are higher and the Cmax is lower than those produced by an oral contraceptive containing NGM 250 mcg / EE 35 mcg. [See Boxed Warning and Clinical Pharmacology (12.3).]. Xulane is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a peach flexible film consisting of a pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutene adhesive, crospovidone, mineral oil, non-woven polyester fabric, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN and EE. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyester film with a fluoropolymer coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Xulane® (norelgestromin and ethinyl estradiol) 150/35 mcg per day” in brown ink. Xulane transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These pieces of protective film are removed and discarded at the time of use. The structural formulas of the components are. Molecular weight, NGMN: 327.47. Molecular weight, EE: 296.41. Chemical name for NGMN: 18, 19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-, 17-hydroxy, 3-oxime, (17α)-. Chemical name for EE: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17β-diol, (17α)-.</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>13668-538-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-538-05) </PackageDescription>
<NDC11Code>13668-0538-05</NDC11Code>
<ProductNDC>13668-538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211227</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30).</Description>
</NDC>
<NDC>
<NDCCode>13668-538-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-538-30) </PackageDescription>
<NDC11Code>13668-0538-30</NDC11Code>
<ProductNDC>13668-538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211227</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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<LastUpdate>2025-07-31</LastUpdate>
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<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.33. The chemical structure is:. Eslicarbazepine acetate is a white to off-white color powder, slightly hygroscopic. It is soluble in methanol, acetonitrile and in dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, glyceryl mono stearate, povidone and sodium stearyl fumarate.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-429-32) / 8 TABLET in 1 BLISTER PACK (31722-429-31) </PackageDescription>
<NDC11Code>31722-0429-32</NDC11Code>
<ProductNDC>31722-429</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211186</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-26</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.33. The chemical structure is:. Eslicarbazepine acetate is a white to off-white color powder, slightly hygroscopic. It is soluble in methanol, acetonitrile and in dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, glyceryl mono stearate, povidone and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>31722-430-32</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-430-32) / 10 TABLET in 1 BLISTER PACK (31722-430-31) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
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<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.33. The chemical structure is:. Eslicarbazepine acetate is a white to off-white color powder, slightly hygroscopic. It is soluble in methanol, acetonitrile and in dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, glyceryl mono stearate, povidone and sodium stearyl fumarate.</Description>
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