{
"NDC": [
{
"NDCCode": "69842-296-73",
"PackageDescription": "355 mL in 1 BOTTLE (69842-296-73) ",
"NDC11Code": "69842-0296-73",
"ProductNDC": "69842-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Antacid Mint",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "CVS",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "800; 800; 80",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 the symptoms referred to as gas."
},
{
"NDCCode": "84126-296-73",
"PackageDescription": "73 g in 1 CYLINDER (84126-296-73) ",
"NDC11Code": "84126-0296-73",
"ProductNDC": "84126-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Old Spice Jamaal Day And Night",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "69842-090-22",
"PackageDescription": "1 TUBE in 1 CARTON (69842-090-22) > 73 g in 1 TUBE",
"NDC11Code": "69842-0090-22",
"ProductNDC": "69842-090",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica",
"NonProprietaryName": "Cvs Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "CVS Health",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-09",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231"
},
{
"NDCCode": "69842-154-73",
"PackageDescription": "150 g in 1 CAN (69842-154-73)",
"NDC11Code": "69842-0154-73",
"ProductNDC": "69842-154",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Athletes Foot",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "69842-342-73",
"PackageDescription": "119 g in 1 BOX (69842-342-73)",
"NDC11Code": "69842-0342-73",
"ProductNDC": "69842-342",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Advanced Acne Therapy",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "For for the treatment of acne."
},
{
"NDCCode": "69842-374-06",
"PackageDescription": "1 CYLINDER in 1 CARTON (69842-374-06) > 73 mL in 1 CYLINDER (69842-374-01) ",
"NDC11Code": "69842-0374-06",
"ProductNDC": "69842-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Maximum Strength Cold And Hot Pain Relief",
"ProprietaryNameSuffix": "Topical Analgesic",
"NonProprietaryName": "Menthol, Unspecified Form",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "CVS Health",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "160",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pain muscles and joints associated with: 1 ♦simple backache, 2 ♦arthritis, 3 ♦strains, 4 ♦bruises and sprains, 5 ♦cramps."
},
{
"NDCCode": "69842-104-10",
"PackageDescription": "296 mL in 1 CAN (69842-104-10) ",
"NDC11Code": "69842-0104-10",
"ProductNDC": "69842-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health",
"ProprietaryNameSuffix": "Sport Spf 30 Clear",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151023",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 20; 40",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"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": "69842-108-10",
"PackageDescription": "296 mL in 1 CAN (69842-108-10) ",
"NDC11Code": "69842-0108-10",
"ProductNDC": "69842-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Pharmacy",
"ProprietaryNameSuffix": "Kids Spf 50 Clear",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20061122",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 40; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20061122",
"SamplePackage": "N",
"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": "69842-111-10",
"PackageDescription": "296 mL in 1 CAN (69842-111-10) ",
"NDC11Code": "69842-0111-10",
"ProductNDC": "69842-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health",
"ProprietaryNameSuffix": "Spf 30 Clear",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151023",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 20; 40",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"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": "69842-116-10",
"PackageDescription": "296 mL in 1 BOTTLE, SPRAY (69842-116-10) ",
"NDC11Code": "69842-0116-10",
"ProductNDC": "69842-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health",
"ProprietaryNameSuffix": "Sport Spf 50 Clear",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170306",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 40; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"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": "69842-127-10",
"PackageDescription": "296 mL in 1 CAN (69842-127-10) ",
"NDC11Code": "69842-0127-10",
"ProductNDC": "69842-127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health",
"ProprietaryNameSuffix": "Spf 70 Clear",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151023",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 150; 50; 100; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"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": "69842-380-38",
"PackageDescription": "296 mL in 1 BOTTLE, GLASS (69842-380-38) ",
"NDC11Code": "69842-0380-38",
"ProductNDC": "69842-380",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citroma",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110923",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "CVS Pharmacy Inc",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.61mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110923",
"SamplePackage": "N"
},
{
"NDCCode": "69842-647-38",
"PackageDescription": "296 mL in 1 BOTTLE, PLASTIC (69842-647-38) ",
"NDC11Code": "69842-0647-38",
"ProductNDC": "69842-647",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citroma",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180218",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). . Generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "69842-763-38",
"PackageDescription": "296 mL in 1 BOTTLE, PLASTIC (69842-763-38) ",
"NDC11Code": "69842-0763-38",
"ProductNDC": "69842-763",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesium Citrate",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180218",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "69842-983-38",
"PackageDescription": "296 mL in 1 BOTTLE, PLASTIC (69842-983-38) ",
"NDC11Code": "69842-0983-38",
"ProductNDC": "69842-983",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citroma",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180218",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours."
},
{
"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": "57297-844-73",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (57297-844-73) / 1 KIT in 1 BLISTER PACK (57297-844-71) * 21 TABLET in 1 BLISTER PACK (57297-841-74) * 7 TABLET in 1 BLISTER PACK (57297-842-74) ",
"NDC11Code": "57297-0844-73",
"ProductNDC": "57297-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kurvelo",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20200318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091408",
"LabelerName": "LUPIN LIMITED",
"Status": "Deprecated",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200318",
"SamplePackage": "N",
"IndicationAndUsage": "Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Kurvelo (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 light-orange active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel C21H28O2 MW: 312.4. Levonorgestrel is chemically (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one). Ethinyl Estradiol C20H24O2 MW: 296.4. Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each light-orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each pink inert tablet contains the following inactive ingredients: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "68180-275-73",
"PackageDescription": "3 POUCH in 1 CARTON (68180-275-73) / 1 KIT in 1 POUCH (68180-275-71) * 2 TABLET, FILM COATED in 1 BLISTER PACK (68180-318-74) * 5 TABLET, FILM COATED in 1 BLISTER PACK (68180-340-74) * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-299-74) ",
"NDC11Code": "68180-0275-73",
"ProductNDC": "68180-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bekyree",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202226",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180120",
"SamplePackage": "N",
"IndicationAndUsage": "Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR, UNITED STATES.",
"Description": "Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) provide an oral contraceptive regimen of 21 white round biconvex tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc, vitamin E and opadry white, a film coating made of hypromellose, polyethylene glycol, and titanium dioxide, followed by 2 inert green, mottled, round, biconvex tablets with the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Bekyree also contains 5 yellow round biconvex tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc, vitamin E and opadry yellow, a film coating made of FD&C Yellow No. 5 Aluminum Lake, hypromellose, iron oxide yellow, polyethylene glycol, and titanium dioxide. The molecular weights for desogestrel and ethinyl estradiol are 310.5 and 296.40 respectively. The structural formulas are as follows. Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.02 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "68180-827-73",
"PackageDescription": "3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68180-0827-73",
"ProductNDC": "68180-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fyavolv",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204213",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".0025; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).",
"Description": "Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available. Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with \"F51\" on one side and \"LU\" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with \"F52\" on one side and \"LU\" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Molecular Weight: 296.40. Molecular Formula: C20H24O2. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. Molecular Weight: 340.46. Molecular Formula: C22H28O3."
},
{
"NDCCode": "68180-828-73",
"PackageDescription": "3 POUCH in 1 CARTON (68180-828-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68180-0828-73",
"ProductNDC": "68180-828",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fyavolv",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204213",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".005; 1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).",
"Description": "Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available. Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with \"F51\" on one side and \"LU\" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with \"F52\" on one side and \"LU\" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Molecular Weight: 296.40. Molecular Formula: C20H24O2. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. Molecular Weight: 340.46. Molecular Formula: C22H28O3."
},
{
"NDCCode": "68180-844-73",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68180-844-73) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74) ",
"NDC11Code": "68180-0844-73",
"ProductNDC": "68180-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kurvelo",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091408",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210207",
"SamplePackage": "N",
"IndicationAndUsage": "Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Kurvelo (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 light-orange active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-. Ethinyl Estradiol C20H24O2 MW: 296.4. Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each light-orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each pink inert tablet contains the following inactive ingredients: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "68180-886-73",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68180-886-73) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "68180-0886-73",
"ProductNDC": "68180-886",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nikki",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20191130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201661",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191130",
"SamplePackage": "N",
"IndicationAndUsage": "Nikki (drospirenone and ethinyl estradiol tablets USP) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg provides an oral contraceptive regimen consisting of 24 pink, round, biconvex active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 white to off-white inert film-coated tablets. The inactive ingredients in the pink film-coated tablets are corn starch, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, pregelatinised starch, talc and titanium dioxide. The white to off-white inert film-coated tablets contain corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch and titanium dioxide. Drospirenone (6R, 7R, 8R, 9S, 10R, 13S, 14S, 15S, 16S, 17S) - 1, 3', 4', 6, 6a, 7, 8, 9, 10, 11, 12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16] cyclopenta [a] phenanthrene- 17, 2' (5H)- furan]-3, 5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17a-pregna 1, 3, 5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "77335-001-24",
"PackageDescription": ".296 L in 1 BOTTLE (77335-001-24) ",
"NDC11Code": "77335-0001-24",
"ProductNDC": "77335-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "W.r.lulus Rinse-free Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Lulus import and export co., ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73.7",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitize to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "69842-000-03",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (69842-000-03) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "69842-0000-03",
"ProductNDC": "69842-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20160725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208150",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160725",
"SamplePackage": "N"
},
{
"NDCCode": "69842-001-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (69842-001-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "69842-0001-01",
"ProductNDC": "69842-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Budesonide",
"NonProprietaryName": "Budesonide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078949",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "32",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 itchy nose , 4 sneezing."
},
{
"NDCCode": "69842-002-35",
"PackageDescription": "1 KIT in 1 CARTON (69842-002-35) * 1 BOTTLE in 1 CARTON (69842-004-20) > 237 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69842-003-20) > 237 mL in 1 BOTTLE",
"NDC11Code": "69842-0002-35",
"ProductNDC": "69842-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime And Nighttime Pain Relief",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20151209",
"EndMarketingDate": "20220701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "CVS Pharmacy, Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151209",
"EndMarketingDatePackage": "20220701",
"SamplePackage": "N"
},
{
"NDCCode": "69842-005-40",
"PackageDescription": "354 mL in 1 BOTTLE (69842-005-40) ",
"NDC11Code": "69842-0005-40",
"ProductNDC": "69842-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief Maximum Strength",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "1050",
"StrengthUnit": "mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N"
},
{
"NDCCode": "69842-006-24",
"PackageDescription": "118 mL in 1 BOTTLE (69842-006-24) ",
"NDC11Code": "69842-0006-24",
"ProductNDC": "69842-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs - Childrens Mucus Relief Cough, Cold And Sore Throat",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20160503",
"EndMarketingDate": "20220401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160503",
"EndMarketingDatePackage": "20220401",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69842-296-73</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (69842-296-73) </PackageDescription>
<NDC11Code>69842-0296-73</NDC11Code>
<ProductNDC>69842-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Antacid Mint</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>800; 800; 80</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 the symptoms referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84126-296-73</NDCCode>
<PackageDescription>73 g in 1 CYLINDER (84126-296-73) </PackageDescription>
<NDC11Code>84126-0296-73</NDC11Code>
<ProductNDC>84126-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Old Spice Jamaal Day And Night</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-090-22</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69842-090-22) > 73 g in 1 TUBE</PackageDescription>
<NDC11Code>69842-0090-22</NDC11Code>
<ProductNDC>69842-090</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica</ProprietaryName>
<NonProprietaryName>Cvs Arnica Montana</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>CVS Health</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69842-154-73</NDCCode>
<PackageDescription>150 g in 1 CAN (69842-154-73)</PackageDescription>
<NDC11Code>69842-0154-73</NDC11Code>
<ProductNDC>69842-154</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Athletes Foot</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69842-342-73</NDCCode>
<PackageDescription>119 g in 1 BOX (69842-342-73)</PackageDescription>
<NDC11Code>69842-0342-73</NDC11Code>
<ProductNDC>69842-342</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Advanced Acne Therapy</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-374-06</NDCCode>
<PackageDescription>1 CYLINDER in 1 CARTON (69842-374-06) > 73 mL in 1 CYLINDER (69842-374-01) </PackageDescription>
<NDC11Code>69842-0374-06</NDC11Code>
<ProductNDC>69842-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Maximum Strength Cold And Hot Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Topical Analgesic</ProprietaryNameSuffix>
<NonProprietaryName>Menthol, Unspecified Form</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>CVS Health</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pain muscles and joints associated with: 1 ♦simple backache, 2 ♦arthritis, 3 ♦strains, 4 ♦bruises and sprains, 5 ♦cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-104-10</NDCCode>
<PackageDescription>296 mL in 1 CAN (69842-104-10) </PackageDescription>
<NDC11Code>69842-0104-10</NDC11Code>
<ProductNDC>69842-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health</ProprietaryName>
<ProprietaryNameSuffix>Sport Spf 30 Clear</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 20; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-108-10</NDCCode>
<PackageDescription>296 mL in 1 CAN (69842-108-10) </PackageDescription>
<NDC11Code>69842-0108-10</NDC11Code>
<ProductNDC>69842-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Pharmacy</ProprietaryName>
<ProprietaryNameSuffix>Kids Spf 50 Clear</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20061122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 40; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-111-10</NDCCode>
<PackageDescription>296 mL in 1 CAN (69842-111-10) </PackageDescription>
<NDC11Code>69842-0111-10</NDC11Code>
<ProductNDC>69842-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health</ProprietaryName>
<ProprietaryNameSuffix>Spf 30 Clear</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 20; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-116-10</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, SPRAY (69842-116-10) </PackageDescription>
<NDC11Code>69842-0116-10</NDC11Code>
<ProductNDC>69842-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health</ProprietaryName>
<ProprietaryNameSuffix>Sport Spf 50 Clear</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 40; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-127-10</NDCCode>
<PackageDescription>296 mL in 1 CAN (69842-127-10) </PackageDescription>
<NDC11Code>69842-0127-10</NDC11Code>
<ProductNDC>69842-127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health</ProprietaryName>
<ProprietaryNameSuffix>Spf 70 Clear</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 150; 50; 100; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-380-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, GLASS (69842-380-38) </PackageDescription>
<NDC11Code>69842-0380-38</NDC11Code>
<ProductNDC>69842-380</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citroma</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>CVS Pharmacy Inc</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.61mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-647-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, PLASTIC (69842-647-38) </PackageDescription>
<NDC11Code>69842-0647-38</NDC11Code>
<ProductNDC>69842-647</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citroma</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). . Generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-763-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, PLASTIC (69842-763-38) </PackageDescription>
<NDC11Code>69842-0763-38</NDC11Code>
<ProductNDC>69842-763</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesium Citrate</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-983-38</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, PLASTIC (69842-983-38) </PackageDescription>
<NDC11Code>69842-0983-38</NDC11Code>
<ProductNDC>69842-983</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citroma</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</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>57297-844-73</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (57297-844-73) / 1 KIT in 1 BLISTER PACK (57297-844-71) * 21 TABLET in 1 BLISTER PACK (57297-841-74) * 7 TABLET in 1 BLISTER PACK (57297-842-74) </PackageDescription>
<NDC11Code>57297-0844-73</NDC11Code>
<ProductNDC>57297-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kurvelo</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091408</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Kurvelo (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 light-orange active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel C21H28O2 MW: 312.4. Levonorgestrel is chemically (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one). Ethinyl Estradiol C20H24O2 MW: 296.4. Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each light-orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each pink inert tablet contains the following inactive ingredients: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>68180-275-73</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (68180-275-73) / 1 KIT in 1 POUCH (68180-275-71) * 2 TABLET, FILM COATED in 1 BLISTER PACK (68180-318-74) * 5 TABLET, FILM COATED in 1 BLISTER PACK (68180-340-74) * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-299-74) </PackageDescription>
<NDC11Code>68180-0275-73</NDC11Code>
<ProductNDC>68180-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bekyree</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202226</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR, UNITED STATES.</IndicationAndUsage>
<Description>Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) provide an oral contraceptive regimen of 21 white round biconvex tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc, vitamin E and opadry white, a film coating made of hypromellose, polyethylene glycol, and titanium dioxide, followed by 2 inert green, mottled, round, biconvex tablets with the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Bekyree also contains 5 yellow round biconvex tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc, vitamin E and opadry yellow, a film coating made of FD&C Yellow No. 5 Aluminum Lake, hypromellose, iron oxide yellow, polyethylene glycol, and titanium dioxide. The molecular weights for desogestrel and ethinyl estradiol are 310.5 and 296.40 respectively. The structural formulas are as follows. Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.02 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68180-827-73</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68180-0827-73</NDC11Code>
<ProductNDC>68180-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fyavolv</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204213</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.0025; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).</IndicationAndUsage>
<Description>Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available. Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with "F51" on one side and "LU" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with "F52" on one side and "LU" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Molecular Weight: 296.40. Molecular Formula: C20H24O2. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. Molecular Weight: 340.46. Molecular Formula: C22H28O3.</Description>
</NDC>
<NDC>
<NDCCode>68180-828-73</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (68180-828-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68180-0828-73</NDC11Code>
<ProductNDC>68180-828</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fyavolv</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204213</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.005; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).</IndicationAndUsage>
<Description>Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available. Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with "F51" on one side and "LU" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with "F52" on one side and "LU" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Molecular Weight: 296.40. Molecular Formula: C20H24O2. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. Molecular Weight: 340.46. Molecular Formula: C22H28O3.</Description>
</NDC>
<NDC>
<NDCCode>68180-844-73</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68180-844-73) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74) </PackageDescription>
<NDC11Code>68180-0844-73</NDC11Code>
<ProductNDC>68180-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kurvelo</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091408</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Kurvelo (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 light-orange active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-. Ethinyl Estradiol C20H24O2 MW: 296.4. Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each light-orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each pink inert tablet contains the following inactive ingredients: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>68180-886-73</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68180-886-73) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68180-0886-73</NDC11Code>
<ProductNDC>68180-886</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nikki</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201661</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nikki (drospirenone and ethinyl estradiol tablets USP) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg provides an oral contraceptive regimen consisting of 24 pink, round, biconvex active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 white to off-white inert film-coated tablets. The inactive ingredients in the pink film-coated tablets are corn starch, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, pregelatinised starch, talc and titanium dioxide. The white to off-white inert film-coated tablets contain corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch and titanium dioxide. Drospirenone (6R, 7R, 8R, 9S, 10R, 13S, 14S, 15S, 16S, 17S) - 1, 3', 4', 6, 6a, 7, 8, 9, 10, 11, 12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16] cyclopenta [a] phenanthrene- 17, 2' (5H)- furan]-3, 5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17a-pregna 1, 3, 5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>77335-001-24</NDCCode>
<PackageDescription>.296 L in 1 BOTTLE (77335-001-24) </PackageDescription>
<NDC11Code>77335-0001-24</NDC11Code>
<ProductNDC>77335-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>W.r.lulus Rinse-free Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Lulus import and export co., ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73.7</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitize to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-000-03</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (69842-000-03) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>69842-0000-03</NDC11Code>
<ProductNDC>69842-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208150</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-001-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (69842-001-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>69842-0001-01</NDC11Code>
<ProductNDC>69842-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Budesonide</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078949</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>32</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 itchy nose , 4 sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-002-35</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69842-002-35) * 1 BOTTLE in 1 CARTON (69842-004-20) > 237 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69842-003-20) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0002-35</NDC11Code>
<ProductNDC>69842-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime And Nighttime Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151209</StartMarketingDate>
<EndMarketingDate>20220701</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<EndMarketingDatePackage>20220701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-005-40</NDCCode>
<PackageDescription>354 mL in 1 BOTTLE (69842-005-40) </PackageDescription>
<NDC11Code>69842-0005-40</NDC11Code>
<ProductNDC>69842-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief Maximum Strength</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>1050</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-006-24</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (69842-006-24) </PackageDescription>
<NDC11Code>69842-0006-24</NDC11Code>
<ProductNDC>69842-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs - Childrens Mucus Relief Cough, Cold And Sore Throat</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160503</StartMarketingDate>
<EndMarketingDate>20220401</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160503</StartMarketingDatePackage>
<EndMarketingDatePackage>20220401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>