{
"NDC": [
{
"NDCCode": "49998-332-16",
"PackageDescription": "1 TINCTURE in 1 BOX (49998-332-16)",
"NDC11Code": "49998-0332-16",
"ProductNDC": "49998-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trival",
"NonProprietaryName": "Homeopathic Alopecia Areata Treatment",
"DosageFormName": "TINCTURE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TE-Point Doo",
"SubstanceName": "URTICA URENS; OLEA EUROPAEA FLOWER; ST. JOHN'S WORT; FRAGARIA VESCA FRUIT; GARLIC; FAGUS SYLVATICA NUT",
"StrengthNumber": "1; 1; 2; 1; 1; 1",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "75682-332-16",
"PackageDescription": "473 mL in 1 BOTTLE, PUMP (75682-332-16) ",
"NDC11Code": "75682-0332-16",
"ProductNDC": "75682-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply 62 Hand Sanitizer Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Froggy's Fog LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77282-332-16",
"PackageDescription": "473 mL in 1 BOTTLE (77282-332-16) ",
"NDC11Code": "77282-0332-16",
"ProductNDC": "77282-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Sustainable Tech LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "10337-332-30",
"PackageDescription": "30 g in 1 TUBE (10337-332-30)",
"NDC11Code": "10337-0332-30",
"ProductNDC": "10337-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cutivate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019958",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.",
"Description": "CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative."
},
{
"NDCCode": "10337-332-60",
"PackageDescription": "60 g in 1 TUBE (10337-332-60)",
"NDC11Code": "10337-0332-60",
"ProductNDC": "10337-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cutivate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019958",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.",
"Description": "CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative."
},
{
"NDCCode": "33342-332-15",
"PackageDescription": "1 TUBE in 1 CARTON (33342-332-15) / 15 g in 1 TUBE",
"NDC11Code": "33342-0332-15",
"ProductNDC": "33342-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209828",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181123",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. The structural formula is. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum."
},
{
"NDCCode": "35000-100-11",
"PackageDescription": "332 mL in 1 BOTTLE (35000-100-11) ",
"NDC11Code": "35000-0100-11",
"ProductNDC": "35000-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Softsoap Antibacterial With Moisturizers Crisp Clean Lhs",
"NonProprietaryName": "Benzalkonium Chloride Liquid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200214",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.33",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200214",
"SamplePackage": "N",
"IndicationAndUsage": "helps eliminate bacteria on hands."
},
{
"NDCCode": "49035-444-68",
"PackageDescription": "332 mL in 1 BOTTLE, PUMP (49035-444-68) ",
"NDC11Code": "49035-0444-68",
"ProductNDC": "49035-444",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180619",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180619",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "50419-332-11",
"PackageDescription": "5 SYRINGE in 1 CARTON (50419-332-11) / 15 mL in 1 SYRINGE (50419-332-01) ",
"NDC11Code": "50419-0332-11",
"ProductNDC": "50419-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambelvist",
"NonProprietaryName": "Gadoquatrane",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260612",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219627",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "GADOQUATRANE",
"StrengthNumber": "257.9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260612",
"SamplePackage": "N",
"IndicationAndUsage": "AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: : 1 the central nervous system (brain, spine, and associated tissues) , 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) .",
"Description": "AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C81H128Gd4N24O32 and a molecular weight of 2,579.1 g/mol. The structural formula of gadoquatrane is. AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. The main physicochemical properties of AMBELVIST are listed in Table 2."
},
{
"NDCCode": "55111-332-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-01) ",
"NDC11Code": "55111-0332-01",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "55111-332-05",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-05) ",
"NDC11Code": "55111-0332-05",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "55111-332-10",
"PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-10) ",
"NDC11Code": "55111-0332-10",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "55111-332-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-30) ",
"NDC11Code": "55111-0332-30",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "55111-332-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-332-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-332-79) ",
"NDC11Code": "55111-0332-78",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "55111-332-81",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (55111-332-81) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-332-79) ",
"NDC11Code": "55111-0332-81",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "55111-332-90",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-90) ",
"NDC11Code": "55111-0332-90",
"ProductNDC": "55111-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077619",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110119",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5."
},
{
"NDCCode": "61314-332-64",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (61314-332-64) / .2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "61314-0332-64",
"ProductNDC": "61314-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "20",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adaz injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen), or as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adaz is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-adaz contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adaz contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-adaz contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of Adalimumab-adaz contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "68001-652-17",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68001-652-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-652-16) ",
"NDC11Code": "68001-0652-17",
"ProductNDC": "68001-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenatane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251230",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "68001-653-17",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68001-653-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-653-16) ",
"NDC11Code": "68001-0653-17",
"ProductNDC": "68001-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenatane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251224",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "68001-654-17",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68001-654-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-654-16) ",
"NDC11Code": "68001-0654-17",
"ProductNDC": "68001-654",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenatane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251223",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "68001-655-17",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68001-655-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-655-16) ",
"NDC11Code": "68001-0655-17",
"ProductNDC": "68001-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenatane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251224",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "68001-708-25",
"PackageDescription": "1 VIAL in 1 CARTON (68001-708-25) / 5 mL in 1 VIAL",
"NDC11Code": "68001-0708-25",
"ProductNDC": "68001-708",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palonosetron",
"NonProprietaryName": "Palonosetron Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205648",
"LabelerName": "BLuePoint Laboratories",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3) receptor antagonist indicated in:. Adults for prevention of: : 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1) , 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1) , 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1) .",
"Description": "Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S)-2-[( S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H-benz[ de]isoquinoline hydrochloride. The empirical formula is C 19H 24N 2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5."
},
{
"NDCCode": "69367-332-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-332-60) ",
"NDC11Code": "69367-0332-60",
"ProductNDC": "69367-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205130",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "Levetiracetam, USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended - release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, hypromellose, povidone, opadry white (03F180003). Opadry white (03F180003) contains hypromellose, titanium dioxide, macrogol and talc. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "69423-332-73",
"PackageDescription": "73 g in 1 CYLINDER (69423-332-73) ",
"NDC11Code": "69423-0332-73",
"ProductNDC": "69423-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Outlast Ph Balanced Invisible Shower Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181013",
"EndMarketingDate": "20211115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181013",
"EndMarketingDatePackage": "20211115",
"SamplePackage": "N"
},
{
"NDCCode": "72865-332-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72865-332-01) ",
"NDC11Code": "72865-0332-01",
"ProductNDC": "72865-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217579",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"Description": "Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate."
},
{
"NDCCode": "72865-332-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (72865-332-10) ",
"NDC11Code": "72865-0332-10",
"ProductNDC": "72865-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217579",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"Description": "Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate."
},
{
"NDCCode": "72865-332-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (72865-332-90) ",
"NDC11Code": "72865-0332-90",
"ProductNDC": "72865-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217579",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"Description": "Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate."
},
{
"NDCCode": "74645-332-74",
"PackageDescription": "1 mL in 1 BOTTLE, PUMP (74645-332-74) ",
"NDC11Code": "74645-0332-74",
"ProductNDC": "74645-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200329",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Organic Ventures L.L.C",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "76420-332-10",
"PackageDescription": "5 POUCH in 1 BOX (76420-332-10) / 2 PATCH in 1 POUCH / 2.7 g in 1 PATCH",
"NDC11Code": "76420-0332-10",
"ProductNDC": "76420-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xiclo",
"NonProprietaryName": "Diclofenac",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20250607",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DICLOFENAC",
"StrengthNumber": ".0125",
"StrengthUnit": "g/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250607",
"SamplePackage": "N",
"IndicationAndUsage": "Xiclo Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.",
"Description": "Xiclo Transdermal Patch is comprised of an adhesive material containing 1.25% diclofenac. Each patch is 2 in x 4 in (5.06 cm x 10.16 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Xiclo Transdermal Patch logo. 2 patches are in each pouch bag. The inactive ingredients include: Glucosamine, Polyacrylate, Vegan Glycerol, and Water. Xiclo Transdermal Patch is Latex Free, Paraben Free, and Vegan."
},
{
"NDCCode": "81583-100-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "81583-0100-01",
"ProductNDC": "81583-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ztalmy",
"NonProprietaryName": "Ganaxolone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220606",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215904",
"LabelerName": "Immedica Pharma US Inc",
"SubstanceName": "GANAXOLONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220606",
"SamplePackage": "N",
"IndicationAndUsage": "ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.",
"Description": "ZTALMY (ganaxolone) oral suspension contains ganaxolone, a neuroactive steroid gamma-aminobutyric acid A (GABAA) receptor positive modulator. Ganaxolone (1-[(3R, 5S, 8R, 9S, 10S, 13S, 14S, 17S)-3-hydroxy-3, 10, 13-trimethyl-1, 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15, 16, 17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone) is a methyl-substituted (at the 3β position) analog of the endogenous neurosteroid allopregnanolone, a derivative of progesterone. Its empirical formula is C22H36O2, and the molecular weight is 332.53 g/mol. The chemical structure is. Ganaxolone is a white to off-white crystalline powder that only exists in one crystal form and has low aqueous solubility. ZTALMY is an oral suspension of ganaxolone. Each mL of oral suspension contains 50 mg of ganaxolone. Inactive ingredients include artificial cherry flavor, citric acid, hypromellose, methylparaben, polyvinyl alcohol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium citrate, sodium lauryl sulfate, and sucralose."
}
]
}
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<NDCList>
<NDC>
<NDCCode>49998-332-16</NDCCode>
<PackageDescription>1 TINCTURE in 1 BOX (49998-332-16)</PackageDescription>
<NDC11Code>49998-0332-16</NDC11Code>
<ProductNDC>49998-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trival</ProprietaryName>
<NonProprietaryName>Homeopathic Alopecia Areata Treatment</NonProprietaryName>
<DosageFormName>TINCTURE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TE-Point Doo</LabelerName>
<SubstanceName>URTICA URENS; OLEA EUROPAEA FLOWER; ST. JOHN'S WORT; FRAGARIA VESCA FRUIT; GARLIC; FAGUS SYLVATICA NUT</SubstanceName>
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<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75682-332-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PUMP (75682-332-16) </PackageDescription>
<NDC11Code>75682-0332-16</NDC11Code>
<ProductNDC>75682-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply 62 Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Froggy's Fog LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77282-332-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (77282-332-16) </PackageDescription>
<NDC11Code>77282-0332-16</NDC11Code>
<ProductNDC>77282-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Sustainable Tech LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10337-332-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (10337-332-30)</PackageDescription>
<NDC11Code>10337-0332-30</NDC11Code>
<ProductNDC>10337-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cutivate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019958</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.</IndicationAndUsage>
<Description>CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-332-60</NDCCode>
<PackageDescription>60 g in 1 TUBE (10337-332-60)</PackageDescription>
<NDC11Code>10337-0332-60</NDC11Code>
<ProductNDC>10337-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cutivate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019958</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.</IndicationAndUsage>
<Description>CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative.</Description>
</NDC>
<NDC>
<NDCCode>33342-332-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (33342-332-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>33342-0332-15</NDC11Code>
<ProductNDC>33342-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209828</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. The structural formula is. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>35000-100-11</NDCCode>
<PackageDescription>332 mL in 1 BOTTLE (35000-100-11) </PackageDescription>
<NDC11Code>35000-0100-11</NDC11Code>
<ProductNDC>35000-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Softsoap Antibacterial With Moisturizers Crisp Clean Lhs</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.33</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-444-68</NDCCode>
<PackageDescription>332 mL in 1 BOTTLE, PUMP (49035-444-68) </PackageDescription>
<NDC11Code>49035-0444-68</NDC11Code>
<ProductNDC>49035-444</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50419-332-11</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (50419-332-11) / 15 mL in 1 SYRINGE (50419-332-01) </PackageDescription>
<NDC11Code>50419-0332-11</NDC11Code>
<ProductNDC>50419-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambelvist</ProprietaryName>
<NonProprietaryName>Gadoquatrane</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260612</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219627</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GADOQUATRANE</SubstanceName>
<StrengthNumber>257.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: : 1 the central nervous system (brain, spine, and associated tissues) , 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) .</IndicationAndUsage>
<Description>AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C81H128Gd4N24O32 and a molecular weight of 2,579.1 g/mol. The structural formula of gadoquatrane is. AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. The main physicochemical properties of AMBELVIST are listed in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-01) </PackageDescription>
<NDC11Code>55111-0332-01</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-05</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-05) </PackageDescription>
<NDC11Code>55111-0332-05</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-10</NDCCode>
<PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-10) </PackageDescription>
<NDC11Code>55111-0332-10</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-30) </PackageDescription>
<NDC11Code>55111-0332-30</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-332-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-332-79) </PackageDescription>
<NDC11Code>55111-0332-78</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-81</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (55111-332-81) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-332-79) </PackageDescription>
<NDC11Code>55111-0332-81</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-332-90</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-332-90) </PackageDescription>
<NDC11Code>55111-0332-90</NDC11Code>
<ProductNDC>55111-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077619</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). Pantoprazole sodium delayed-release tablets USP contains the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein. Pantoprazole sodium delayed-release tablets meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>61314-332-64</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (61314-332-64) / .2 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>61314-0332-64</NDC11Code>
<ProductNDC>61314-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-adaz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761071</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ADALIMUMAB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adaz injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen), or as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adaz is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-adaz contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adaz contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-adaz contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of Adalimumab-adaz contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>68001-652-17</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68001-652-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-652-16) </PackageDescription>
<NDC11Code>68001-0652-17</NDC11Code>
<ProductNDC>68001-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenatane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
</NDC>
<NDC>
<NDCCode>68001-653-17</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68001-653-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-653-16) </PackageDescription>
<NDC11Code>68001-0653-17</NDC11Code>
<ProductNDC>68001-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenatane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
</NDC>
<NDC>
<NDCCode>68001-654-17</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68001-654-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-654-16) </PackageDescription>
<NDC11Code>68001-0654-17</NDC11Code>
<ProductNDC>68001-654</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenatane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
</NDC>
<NDC>
<NDCCode>68001-655-17</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68001-655-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-655-16) </PackageDescription>
<NDC11Code>68001-0655-17</NDC11Code>
<ProductNDC>68001-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenatane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
</NDC>
<NDC>
<NDCCode>68001-708-25</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68001-708-25) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>68001-0708-25</NDC11Code>
<ProductNDC>68001-708</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palonosetron</ProprietaryName>
<NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205648</ApplicationNumber>
<LabelerName>BLuePoint Laboratories</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3) receptor antagonist indicated in:. Adults for prevention of: : 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1) , 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1) , 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1) .</IndicationAndUsage>
<Description>Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S)-2-[( S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H-benz[ de]isoquinoline hydrochloride. The empirical formula is C 19H 24N 2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>69367-332-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-332-60) </PackageDescription>
<NDC11Code>69367-0332-60</NDC11Code>
<ProductNDC>69367-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205130</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>Levetiracetam, USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended - release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, hypromellose, povidone, opadry white (03F180003). Opadry white (03F180003) contains hypromellose, titanium dioxide, macrogol and talc. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69423-332-73</NDCCode>
<PackageDescription>73 g in 1 CYLINDER (69423-332-73) </PackageDescription>
<NDC11Code>69423-0332-73</NDC11Code>
<ProductNDC>69423-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Outlast Ph Balanced Invisible Shower Fresh</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181013</StartMarketingDate>
<EndMarketingDate>20211115</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181013</StartMarketingDatePackage>
<EndMarketingDatePackage>20211115</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72865-332-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72865-332-01) </PackageDescription>
<NDC11Code>72865-0332-01</NDC11Code>
<ProductNDC>72865-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217579</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>72865-332-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (72865-332-10) </PackageDescription>
<NDC11Code>72865-0332-10</NDC11Code>
<ProductNDC>72865-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217579</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>72865-332-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72865-332-90) </PackageDescription>
<NDC11Code>72865-0332-90</NDC11Code>
<ProductNDC>72865-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217579</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>74645-332-74</NDCCode>
<PackageDescription>1 mL in 1 BOTTLE, PUMP (74645-332-74) </PackageDescription>
<NDC11Code>74645-0332-74</NDC11Code>
<ProductNDC>74645-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200329</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Organic Ventures L.L.C</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76420-332-10</NDCCode>
<PackageDescription>5 POUCH in 1 BOX (76420-332-10) / 2 PATCH in 1 POUCH / 2.7 g in 1 PATCH</PackageDescription>
<NDC11Code>76420-0332-10</NDC11Code>
<ProductNDC>76420-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xiclo</ProprietaryName>
<NonProprietaryName>Diclofenac</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20250607</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>DICLOFENAC</SubstanceName>
<StrengthNumber>.0125</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Xiclo Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.</IndicationAndUsage>
<Description>Xiclo Transdermal Patch is comprised of an adhesive material containing 1.25% diclofenac. Each patch is 2 in x 4 in (5.06 cm x 10.16 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Xiclo Transdermal Patch logo. 2 patches are in each pouch bag. The inactive ingredients include: Glucosamine, Polyacrylate, Vegan Glycerol, and Water. Xiclo Transdermal Patch is Latex Free, Paraben Free, and Vegan.</Description>
</NDC>
<NDC>
<NDCCode>81583-100-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>81583-0100-01</NDC11Code>
<ProductNDC>81583-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ztalmy</ProprietaryName>
<NonProprietaryName>Ganaxolone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220606</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215904</ApplicationNumber>
<LabelerName>Immedica Pharma US Inc</LabelerName>
<SubstanceName>GANAXOLONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.</IndicationAndUsage>
<Description>ZTALMY (ganaxolone) oral suspension contains ganaxolone, a neuroactive steroid gamma-aminobutyric acid A (GABAA) receptor positive modulator. Ganaxolone (1-[(3R, 5S, 8R, 9S, 10S, 13S, 14S, 17S)-3-hydroxy-3, 10, 13-trimethyl-1, 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15, 16, 17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone) is a methyl-substituted (at the 3β position) analog of the endogenous neurosteroid allopregnanolone, a derivative of progesterone. Its empirical formula is C22H36O2, and the molecular weight is 332.53 g/mol. The chemical structure is. Ganaxolone is a white to off-white crystalline powder that only exists in one crystal form and has low aqueous solubility. ZTALMY is an oral suspension of ganaxolone. Each mL of oral suspension contains 50 mg of ganaxolone. Inactive ingredients include artificial cherry flavor, citric acid, hypromellose, methylparaben, polyvinyl alcohol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium citrate, sodium lauryl sulfate, and sucralose.</Description>
</NDC>
</NDCList>