{
"NDC": [
{
"NDCCode": "53401-026-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (53401-026-45) ",
"NDC11Code": "53401-0026-45",
"ProductNDC": "53401-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260810",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "53401-009-45",
"PackageDescription": "45 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-009-45) ",
"NDC11Code": "53401-0009-45",
"ProductNDC": "53401-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260512",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "53401-010-45",
"PackageDescription": "45 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-45) ",
"NDC11Code": "53401-0010-45",
"ProductNDC": "53401-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260514",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "53401-013-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (53401-013-45) ",
"NDC11Code": "53401-0013-45",
"ProductNDC": "53401-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260518",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "53401-014-45",
"PackageDescription": "45 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-014-45) ",
"NDC11Code": "53401-0014-45",
"ProductNDC": "53401-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078889",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "53401-018-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (53401-018-45) ",
"NDC11Code": "53401-0018-45",
"ProductNDC": "53401-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260702",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "53401-041-45",
"PackageDescription": "45 TABLET, COATED in 1 BOTTLE (53401-041-45) ",
"NDC11Code": "53401-0041-45",
"ProductNDC": "53401-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040750",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261005",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone is an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosteronism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17 hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N & A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "17381-026-45",
"PackageDescription": "30 kg in 1 DRUM (17381-026-45) ",
"NDC11Code": "17381-0026-45",
"ProductNDC": "17381-026",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Apixaban",
"DosageFormName": "POWDER",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Siegfried Evionnaz SA",
"SubstanceName": "APIXABAN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-02-15",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-DEC-22"
},
{
"NDCCode": "43353-026-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-026-45)",
"NDC11Code": "43353-0026-45",
"ProductNDC": "43353-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076578",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "52959-026-45",
"PackageDescription": "45 TABLET in 1 BOTTLE, PLASTIC (52959-026-45)",
"NDC11Code": "52959-0026-45",
"ProductNDC": "52959-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040124",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].",
"Description": "Carisoprodol Tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "55681-026-45",
"PackageDescription": "128 g in 1 JAR (55681-026-45) ",
"NDC11Code": "55681-0026-45",
"ProductNDC": "55681-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Procure Lanacare",
"NonProprietaryName": "Lanolin 50%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Twin Med LLC",
"SubstanceName": "LANOLIN",
"StrengthNumber": "50",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Temporarily protects minor cuts, scrapes, and burns, 2 Temporarily protects and helps relieve chafed, chapped or cracked skin, 3 Helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "63736-026-15",
"PackageDescription": "7 TUBE, WITH APPLICATOR in 1 CARTON (63736-026-15) / 45 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "63736-0026-15",
"ProductNDC": "63736-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Monistat 7",
"ProprietaryNameSuffix": "7-day Disposable Applicators",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "19930426",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017450",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930426",
"SamplePackage": "N",
"IndicationAndUsage": "treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection."
},
{
"NDCCode": "66854-026-02",
"PackageDescription": "45 mL in 1 BOTTLE (66854-026-02)",
"NDC11Code": "66854-0026-02",
"ProductNDC": "66854-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermaprot",
"ProprietaryNameSuffix": "Helioprot Ab Spf 30",
"NonProprietaryName": "Octinoxate,titanium Dioxide,oxybenzone,avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120630",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OXYBENZONE",
"StrengthNumber": "7.5; 3; 2.5; 1.5",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Provides moderate protection against sun. This product is for topical application."
},
{
"NDCCode": "67544-026-45",
"PackageDescription": "45 TABLET in 1 BOTTLE, PLASTIC (67544-026-45)",
"NDC11Code": "67544-0026-45",
"ProductNDC": "67544-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040084",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69423-026-45",
"PackageDescription": "45 g in 1 CYLINDER (69423-026-45)",
"NDC11Code": "69423-0026-45",
"ProductNDC": "69423-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Scent Expressions Clear Ooh La La Lavender",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150307",
"EndMarketingDate": "20181006",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter and Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
"StrengthNumber": "16",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-10-10",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "71806-026-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 BAG (71806-026-01) / 45 g in 1 BOTTLE, GLASS",
"NDC11Code": "71806-0026-01",
"ProductNDC": "71806-026",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tetrofosmin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20061120",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "GE Healthcare Lindesnes",
"SubstanceName": "TETROFOSMIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-01-11",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20-NOV-06"
},
{
"NDCCode": "14324-026-00",
"PackageDescription": "1 TUBE in 1 CARTON (14324-026-00) / 50 mL in 1 TUBE",
"NDC11Code": "14324-0026-00",
"ProductNDC": "14324-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Photo Regul Cream Unifying Protective Face Care Spf 25",
"NonProprietaryName": "Homosalate, Octisalate, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220401",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Naos USA, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "27; 90; 45",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220401",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "24979-026-00",
"PackageDescription": "42000 CAPSULE, EXTENDED RELEASE in 1 DRUM (24979-026-00) ",
"NDC11Code": "24979-0026-00",
"ProductNDC": "24979-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205231",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending."
},
{
"NDCCode": "24979-026-02",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02) ",
"NDC11Code": "24979-0026-02",
"ProductNDC": "24979-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205231",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending."
},
{
"NDCCode": "24979-026-06",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06) ",
"NDC11Code": "24979-0026-06",
"ProductNDC": "24979-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205231",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending."
},
{
"NDCCode": "24979-026-07",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-07) ",
"NDC11Code": "24979-0026-07",
"ProductNDC": "24979-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205231",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending."
},
{
"NDCCode": "29033-026-02",
"PackageDescription": "200 CAPSULE in 1 BOTTLE (29033-026-02) ",
"NDC11Code": "29033-0026-02",
"ProductNDC": "29033-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Acetate",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203179",
"LabelerName": "Nostrum Laboratories, Inc.",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "667",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).",
"Description": "Calcium acetate capsules, USP act as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Each capsule for oral administration contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equivalent to 169 mg (8.45 mEq) of calcium and and the inactive ingredients magnesium stearate and polyethylene glycol. The capsules are size 00EL with light green opaque cap and white opaque body with black imprint on cap “NC” above “667”. The gelatin capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red # 40, titanium dioxide and gelatin. The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminium Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/ Allura Red AC Aluminum Lake, propylene glycol and shellac glaze. USP dissolution test is pending."
},
{
"NDCCode": "37000-544-45",
"PackageDescription": "12 g in 1 CAN (37000-544-45) ",
"NDC11Code": "37000-0544-45",
"ProductNDC": "37000-544",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Vaporub",
"NonProprietaryName": "Camphor (synthetic), Eucalyptus Oil, And Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930730",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL",
"StrengthNumber": ".048; .012; .026",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N"
},
{
"NDCCode": "37000-711-48",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (37000-711-48) > 48 g in 1 BOTTLE, PUMP",
"NDC11Code": "37000-0711-48",
"ProductNDC": "37000-711",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ddf Weightless Defense Hydrator",
"ProprietaryNameSuffix": "Broad Spectrum Spf 45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121101",
"EndMarketingDate": "20161001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .15; .05; .026; .06",
"StrengthUnit": "g/g; g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "53031-026-01",
"PackageDescription": "60 mL in 1 BOTTLE (53031-026-01) ",
"NDC11Code": "53031-0026-01",
"ProductNDC": "53031-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Dongyang Medical & Hygienic Articles Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "45",
"StrengthUnit": "mL/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "58933-544-45",
"PackageDescription": "12 g in 1 CAN (58933-544-45) ",
"NDC11Code": "58933-0544-45",
"ProductNDC": "58933-544",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Vaporub",
"NonProprietaryName": "Camphor (synthetic), Eucalyptus Oil, And Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930730",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Procter & Gamble Manufactura S de RL de CV",
"SubstanceName": "CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL",
"StrengthNumber": ".048; .012; .026",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930730",
"SamplePackage": "N",
"IndicationAndUsage": "when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold. when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints."
},
{
"NDCCode": "59078-026-01",
"PackageDescription": "50 mL in 1 CARTON (59078-026-01)",
"NDC11Code": "59078-0026-01",
"ProductNDC": "59078-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luminous Auracapsule Cc",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "TONYMOLY CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE",
"StrengthNumber": "4.09; 3.75; 2.5; 2.45",
"StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "84677-026-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-026-05) ",
"NDC11Code": "84677-0026-05",
"ProductNDC": "84677-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "GSMS, Incorporated",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "84677-026-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (84677-026-30) ",
"NDC11Code": "84677-0026-30",
"ProductNDC": "84677-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
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"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
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<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17 hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N & A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
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<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Siegfried Evionnaz SA</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-02-15</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-DEC-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43353-026-45</NDCCode>
<PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-026-45)</PackageDescription>
<NDC11Code>43353-0026-45</NDC11Code>
<ProductNDC>43353-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076578</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52959-026-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (52959-026-45)</PackageDescription>
<NDC11Code>52959-0026-45</NDC11Code>
<ProductNDC>52959-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040124</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].</IndicationAndUsage>
<Description>Carisoprodol Tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>55681-026-45</NDCCode>
<PackageDescription>128 g in 1 JAR (55681-026-45) </PackageDescription>
<NDC11Code>55681-0026-45</NDC11Code>
<ProductNDC>55681-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Procure Lanacare</ProprietaryName>
<NonProprietaryName>Lanolin 50%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Twin Med LLC</LabelerName>
<SubstanceName>LANOLIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Temporarily protects minor cuts, scrapes, and burns, 2 Temporarily protects and helps relieve chafed, chapped or cracked skin, 3 Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-026-15</NDCCode>
<PackageDescription>7 TUBE, WITH APPLICATOR in 1 CARTON (63736-026-15) / 45 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>63736-0026-15</NDC11Code>
<ProductNDC>63736-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Monistat 7</ProprietaryName>
<ProprietaryNameSuffix>7-day Disposable Applicators</ProprietaryNameSuffix>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>19930426</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017450</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66854-026-02</NDCCode>
<PackageDescription>45 mL in 1 BOTTLE (66854-026-02)</PackageDescription>
<NDC11Code>66854-0026-02</NDC11Code>
<ProductNDC>66854-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermaprot</ProprietaryName>
<ProprietaryNameSuffix>Helioprot Ab Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate,titanium Dioxide,oxybenzone,avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OXYBENZONE</SubstanceName>
<StrengthNumber>7.5; 3; 2.5; 1.5</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Provides moderate protection against sun. This product is for topical application.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67544-026-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (67544-026-45)</PackageDescription>
<NDC11Code>67544-0026-45</NDC11Code>
<ProductNDC>67544-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040084</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69423-026-45</NDCCode>
<PackageDescription>45 g in 1 CYLINDER (69423-026-45)</PackageDescription>
<NDC11Code>69423-0026-45</NDC11Code>
<ProductNDC>69423-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Scent Expressions Clear Ooh La La Lavender</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150307</StartMarketingDate>
<EndMarketingDate>20181006</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter and Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>71806-026-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BAG (71806-026-01) / 45 g in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71806-0026-01</NDC11Code>
<ProductNDC>71806-026</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tetrofosmin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20061120</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>GE Healthcare Lindesnes</LabelerName>
<SubstanceName>TETROFOSMIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-11</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-NOV-06</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14324-026-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (14324-026-00) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>14324-0026-00</NDC11Code>
<ProductNDC>14324-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Photo Regul Cream Unifying Protective Face Care Spf 25</ProprietaryName>
<NonProprietaryName>Homosalate, Octisalate, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220401</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Naos USA, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>27; 90; 45</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24979-026-00</NDCCode>
<PackageDescription>42000 CAPSULE, EXTENDED RELEASE in 1 DRUM (24979-026-00) </PackageDescription>
<NDC11Code>24979-0026-00</NDC11Code>
<ProductNDC>24979-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205231</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>24979-026-02</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02) </PackageDescription>
<NDC11Code>24979-0026-02</NDC11Code>
<ProductNDC>24979-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205231</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>24979-026-06</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06) </PackageDescription>
<NDC11Code>24979-0026-06</NDC11Code>
<ProductNDC>24979-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205231</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>24979-026-07</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-07) </PackageDescription>
<NDC11Code>24979-0026-07</NDC11Code>
<ProductNDC>24979-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205231</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>29033-026-02</NDCCode>
<PackageDescription>200 CAPSULE in 1 BOTTLE (29033-026-02) </PackageDescription>
<NDC11Code>29033-0026-02</NDC11Code>
<ProductNDC>29033-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Acetate</ProprietaryName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203179</ApplicationNumber>
<LabelerName>Nostrum Laboratories, Inc.</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>667</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).</IndicationAndUsage>
<Description>Calcium acetate capsules, USP act as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Each capsule for oral administration contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equivalent to 169 mg (8.45 mEq) of calcium and and the inactive ingredients magnesium stearate and polyethylene glycol. The capsules are size 00EL with light green opaque cap and white opaque body with black imprint on cap “NC” above “667”. The gelatin capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red # 40, titanium dioxide and gelatin. The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminium Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/ Allura Red AC Aluminum Lake, propylene glycol and shellac glaze. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>37000-544-45</NDCCode>
<PackageDescription>12 g in 1 CAN (37000-544-45) </PackageDescription>
<NDC11Code>37000-0544-45</NDC11Code>
<ProductNDC>37000-544</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Vaporub</ProprietaryName>
<NonProprietaryName>Camphor (synthetic), Eucalyptus Oil, And Menthol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL</SubstanceName>
<StrengthNumber>.048; .012; .026</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-711-48</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (37000-711-48) > 48 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>37000-0711-48</NDC11Code>
<ProductNDC>37000-711</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ddf Weightless Defense Hydrator</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 45</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121101</StartMarketingDate>
<EndMarketingDate>20161001</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .15; .05; .026; .06</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>53031-026-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (53031-026-01) </PackageDescription>
<NDC11Code>53031-0026-01</NDC11Code>
<ProductNDC>53031-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Dongyang Medical & Hygienic Articles Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mL/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58933-544-45</NDCCode>
<PackageDescription>12 g in 1 CAN (58933-544-45) </PackageDescription>
<NDC11Code>58933-0544-45</NDC11Code>
<ProductNDC>58933-544</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Vaporub</ProprietaryName>
<NonProprietaryName>Camphor (synthetic), Eucalyptus Oil, And Menthol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Procter & Gamble Manufactura S de RL de CV</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL</SubstanceName>
<StrengthNumber>.048; .012; .026</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold. when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59078-026-01</NDCCode>
<PackageDescription>50 mL in 1 CARTON (59078-026-01)</PackageDescription>
<NDC11Code>59078-0026-01</NDC11Code>
<ProductNDC>59078-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luminous Auracapsule Cc</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>TONYMOLY CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4.09; 3.75; 2.5; 2.45</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84677-026-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-026-05) </PackageDescription>
<NDC11Code>84677-0026-05</NDC11Code>
<ProductNDC>84677-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-026-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (84677-026-30) </PackageDescription>
<NDC11Code>84677-0026-30</NDC11Code>
<ProductNDC>84677-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-026-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (84677-026-90) </PackageDescription>
<NDC11Code>84677-0026-90</NDC11Code>
<ProductNDC>84677-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
</NDCList>