{
"NDC": [
{
"NDCCode": "51672-4116-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-4116-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-4116-02",
"ProductNDC": "51672-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077819",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060718",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.",
"Description": "Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H-imidazole-1-ethanol and has the following structure:."
},
{
"NDCCode": "0498-4116-01",
"PackageDescription": "1 KIT in 1 KIT (0498-4116-01) * .9 g in 1 PACKET * 1.4 mL in 1 PACKET * .9 g in 1 PACKET (0498-0730-01) * 1.3 mL in 1 PACKET * .4 mL in 1 POUCH * 2 TABLET in 1 PACKET (0498-2001-01) * 30 mL in 1 BOTTLE (0498-0100-01) ",
"NDC11Code": "00498-4116-01",
"ProductNDC": "0498-4116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4116 First Aid Kit",
"NonProprietaryName": "4116 First Aid Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20181018",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Honeywell Safety Products USA, INC",
"Status": "Deprecated",
"LastUpdate": "2024-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181018",
"SamplePackage": "N"
},
{
"NDCCode": "37662-4116-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-4116-2) ",
"NDC11Code": "37662-4116-02",
"ProductNDC": "37662-4116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanadium Muriaticum",
"NonProprietaryName": "Vanadium Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231009",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "VANADIUM(II) CHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231009",
"SamplePackage": "N"
},
{
"NDCCode": "51672-4116-5",
"PackageDescription": "5 g in 1 TUBE (51672-4116-5) ",
"NDC11Code": "51672-4116-05",
"ProductNDC": "51672-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077819",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060718",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.",
"Description": "Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H-imidazole-1-ethanol and has the following structure:."
},
{
"NDCCode": "51672-4116-6",
"PackageDescription": "1 TUBE in 1 CARTON (51672-4116-6) / 45 g in 1 TUBE",
"NDC11Code": "51672-4116-06",
"ProductNDC": "51672-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077819",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060718",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.",
"Description": "Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H-imidazole-1-ethanol and has the following structure:."
},
{
"NDCCode": "0002-4116-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0002-4116-30) ",
"NDC11Code": "00002-4116-30",
"ProductNDC": "0002-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyprexa",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020592",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961001",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
},
{
"NDCCode": "0527-4116-37",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) ",
"NDC11Code": "00527-4116-37",
"ProductNDC": "0527-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0527-4116-41",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) ",
"NDC11Code": "00527-4116-41",
"ProductNDC": "0527-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "43419-315-06",
"PackageDescription": "1 CONTAINER in 1 CARTON (43419-315-06) > 14 g in 1 CONTAINER",
"NDC11Code": "43419-0315-06",
"ProductNDC": "43419-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iope Retigen Smoothing Pact",
"ProprietaryNameSuffix": "No.2 Spf25 Pa Plus Plus",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".84; .86912; .4116",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Deprecated",
"LastUpdate": "2018-10-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50090-4116-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-4116-0) ",
"NDC11Code": "50090-4116-00",
"ProductNDC": "50090-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acarbose",
"NonProprietaryName": "Acarbose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020482",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ACARBOSE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "Acarbose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Acarbose is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically known as O-4,6-dideoxy- 4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-α-D-glucopyranosyl-(1 → 4)-O-α-D-glucopyranosyl-(1 → 4)-D-glucose. It is a white to off-white powder with a molecular weight of 645.6. Acarbose is soluble in water and has a pKa of 5.1. Its empirical formula is C25H43NO18 and its chemical structure is as follows: 1 ."
},
{
"NDCCode": "51672-1253-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1253-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1253-02",
"ProductNDC": "51672-1253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019117",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840626",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1254-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1254-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1254-02",
"ProductNDC": "51672-1254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19890119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072494",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19890119",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1258-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1258-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1258-02",
"ProductNDC": "51672-1258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074249",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960708",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "51672-1259-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1259-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1259-02",
"ProductNDC": "51672-1259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074248",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960712",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "51672-1261-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1261-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1261-02",
"ProductNDC": "51672-1261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074904",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980714",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1262-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1262-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1262-02",
"ProductNDC": "51672-1262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074286",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960607",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1263-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1263-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1263-02",
"ProductNDC": "51672-1263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19871222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062364",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19871222",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. 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 white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "51672-1264-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1264-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1264-02",
"ProductNDC": "51672-1264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075008",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19990630",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1270-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1270-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1270-02",
"ProductNDC": "51672-1270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073193",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901130",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1270-9",
"PackageDescription": "2 TUBE in 1 CARTON (51672-1270-9) > 100 g in 1 TUBE",
"NDC11Code": "51672-1270-09",
"ProductNDC": "51672-1270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073193",
"LabelerName": "Taro Pharmaceuticals U.S.A., Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "51672-1271-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1271-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1271-02",
"ProductNDC": "51672-1271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073210",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901130",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1272-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1272-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1272-02",
"ProductNDC": "51672-1272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063305",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930329",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. 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 white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "51672-1273-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51672-1273-2) / 20 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "51672-1273-02",
"ProductNDC": "51672-1273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074799",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19961231",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α, 11β, 16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1275-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1275-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1275-02",
"ProductNDC": "51672-1275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072640",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930831",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis.",
"Description": "Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22H 17ClN 2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "51672-1275-7",
"PackageDescription": "2 TUBE in 1 CARTON (51672-1275-7) / 45 g in 1 TUBE",
"NDC11Code": "51672-1275-07",
"ProductNDC": "51672-1275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072640",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930831",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis.",
"Description": "Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22H 17ClN 2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "51672-1279-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1279-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1279-02",
"ProductNDC": "51672-1279",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19970729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074935",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970729",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1282-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1282-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1282-02",
"ProductNDC": "51672-1282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19971126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040039",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971126",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone acetonide cream, 0.1% 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. Each gram of 0.1% triamcinolone acetonide cream provides 1 mg triamcinolone acetonide, respectively, in a vanishing cream base containing cetyl alcohol, cetyl esters wax, glyceryl monostearate, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water."
},
{
"NDCCode": "51672-1284-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1284-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1284-02",
"ProductNDC": "51672-1284",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040037",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161026",
"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 anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-. The structural formula is. Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1 mg triamcinolone acetonide, in an ointment base of fractionated coconut oil and white petrolatum, with methylparaben and propylparaben as preservatives."
},
{
"NDCCode": "51672-1289-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE",
"NDC11Code": "51672-1289-02",
"ProductNDC": "51672-1289",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064022",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930128",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candidaspecies. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula. Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment."
},
{
"NDCCode": "51672-1293-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-2) / 25 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "51672-1293-02",
"ProductNDC": "51672-1293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19981116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075224",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19981116",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.",
"Description": "Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione and it has the following structural formula. Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base composed of carbomer 934P, isopropyl alcohol (39.3%), purified water, and sodium hydroxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51672-4116-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-4116-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-4116-02</NDC11Code>
<ProductNDC>51672-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077819</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.</IndicationAndUsage>
<Description>Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H-imidazole-1-ethanol and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>0498-4116-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0498-4116-01) * .9 g in 1 PACKET * 1.4 mL in 1 PACKET * .9 g in 1 PACKET (0498-0730-01) * 1.3 mL in 1 PACKET * .4 mL in 1 POUCH * 2 TABLET in 1 PACKET (0498-2001-01) * 30 mL in 1 BOTTLE (0498-0100-01) </PackageDescription>
<NDC11Code>00498-4116-01</NDC11Code>
<ProductNDC>0498-4116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4116 First Aid Kit</ProprietaryName>
<NonProprietaryName>4116 First Aid Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181018</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Honeywell Safety Products USA, INC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-4116-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-4116-2) </PackageDescription>
<NDC11Code>37662-4116-02</NDC11Code>
<ProductNDC>37662-4116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanadium Muriaticum</ProprietaryName>
<NonProprietaryName>Vanadium Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231009</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>VANADIUM(II) CHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51672-4116-5</NDCCode>
<PackageDescription>5 g in 1 TUBE (51672-4116-5) </PackageDescription>
<NDC11Code>51672-4116-05</NDC11Code>
<ProductNDC>51672-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077819</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.</IndicationAndUsage>
<Description>Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H-imidazole-1-ethanol and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>51672-4116-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-4116-6) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-4116-06</NDC11Code>
<ProductNDC>51672-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077819</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.</IndicationAndUsage>
<Description>Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H-imidazole-1-ethanol and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>0002-4116-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0002-4116-30) </PackageDescription>
<NDC11Code>00002-4116-30</NDC11Code>
<ProductNDC>0002-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyprexa</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020592</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0527-4116-37</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) </PackageDescription>
<NDC11Code>00527-4116-37</NDC11Code>
<ProductNDC>0527-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212026</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>0527-4116-41</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) </PackageDescription>
<NDC11Code>00527-4116-41</NDC11Code>
<ProductNDC>0527-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212026</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>43419-315-06</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (43419-315-06) > 14 g in 1 CONTAINER</PackageDescription>
<NDC11Code>43419-0315-06</NDC11Code>
<ProductNDC>43419-315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iope Retigen Smoothing Pact</ProprietaryName>
<ProprietaryNameSuffix>No.2 Spf25 Pa Plus Plus</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.84; .86912; .4116</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-4116-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-4116-0) </PackageDescription>
<NDC11Code>50090-4116-00</NDC11Code>
<ProductNDC>50090-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acarbose</ProprietaryName>
<NonProprietaryName>Acarbose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020482</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ACARBOSE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acarbose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Acarbose is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically known as O-4,6-dideoxy- 4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-α-D-glucopyranosyl-(1 → 4)-O-α-D-glucopyranosyl-(1 → 4)-D-glucose. It is a white to off-white powder with a molecular weight of 645.6. Acarbose is soluble in water and has a pKa of 5.1. Its empirical formula is C25H43NO18 and its chemical structure is as follows: 1 .</Description>
</NDC>
<NDC>
<NDCCode>51672-1253-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1253-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1253-02</NDC11Code>
<ProductNDC>51672-1253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019117</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1254-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1254-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1254-02</NDC11Code>
<ProductNDC>51672-1254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19890119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072494</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1258-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1258-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1258-02</NDC11Code>
<ProductNDC>51672-1258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074249</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1259-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1259-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1259-02</NDC11Code>
<ProductNDC>51672-1259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074248</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1261-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1261-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1261-02</NDC11Code>
<ProductNDC>51672-1261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074904</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1262-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1262-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1262-02</NDC11Code>
<ProductNDC>51672-1262</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074286</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1263-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1263-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1263-02</NDC11Code>
<ProductNDC>51672-1263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19871222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062364</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19871222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. 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 white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1264-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1264-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1264-02</NDC11Code>
<ProductNDC>51672-1264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075008</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1270-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1270-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1270-02</NDC11Code>
<ProductNDC>51672-1270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073193</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1270-9</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (51672-1270-9) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1270-09</NDC11Code>
<ProductNDC>51672-1270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073193</ApplicationNumber>
<LabelerName>Taro Pharmaceuticals U.S.A., Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>51672-1271-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1271-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1271-02</NDC11Code>
<ProductNDC>51672-1271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073210</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1272-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1272-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1272-02</NDC11Code>
<ProductNDC>51672-1272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063305</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. 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 white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1273-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51672-1273-2) / 20 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51672-1273-02</NDC11Code>
<ProductNDC>51672-1273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074799</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α, 11β, 16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1275-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1275-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1275-02</NDC11Code>
<ProductNDC>51672-1275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072640</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22H 17ClN 2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative.</Description>
</NDC>
<NDC>
<NDCCode>51672-1275-7</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (51672-1275-7) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1275-07</NDC11Code>
<ProductNDC>51672-1275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072640</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22H 17ClN 2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative.</Description>
</NDC>
<NDC>
<NDCCode>51672-1279-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1279-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1279-02</NDC11Code>
<ProductNDC>51672-1279</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19970729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074935</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1282-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1282-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1282-02</NDC11Code>
<ProductNDC>51672-1282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19971126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040039</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone acetonide cream, 0.1% 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. Each gram of 0.1% triamcinolone acetonide cream provides 1 mg triamcinolone acetonide, respectively, in a vanishing cream base containing cetyl alcohol, cetyl esters wax, glyceryl monostearate, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.</Description>
</NDC>
<NDC>
<NDCCode>51672-1284-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1284-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1284-02</NDC11Code>
<ProductNDC>51672-1284</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040037</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161026</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 anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-. The structural formula is. Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1 mg triamcinolone acetonide, in an ointment base of fractionated coconut oil and white petrolatum, with methylparaben and propylparaben as preservatives.</Description>
</NDC>
<NDC>
<NDCCode>51672-1289-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1289-02</NDC11Code>
<ProductNDC>51672-1289</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064022</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candidaspecies. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula. Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>51672-1293-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-2) / 25 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51672-1293-02</NDC11Code>
<ProductNDC>51672-1293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19981116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075224</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
<Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione and it has the following structural formula. Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base composed of carbomer 934P, isopropyl alcohol (39.3%), purified water, and sodium hydroxide.</Description>
</NDC>
</NDCList>