{
"NDC": [
{
"NDCCode": "10337-395-60",
"PackageDescription": "1 TUBE in 1 CARTON (10337-395-60) > 60 g in 1 TUBE",
"NDC11Code": "10337-0395-60",
"ProductNDC": "10337-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apexicon E",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20021220",
"EndMarketingDate": "20230428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076263",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20230428",
"SamplePackage": "N"
},
{
"NDCCode": "10337-395-08",
"PackageDescription": "2 g in 1 TUBE (10337-395-08) ",
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"ProductNDC": "10337-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apexicon E",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20021220",
"EndMarketingDate": "20230428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076263",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20021220",
"EndMarketingDatePackage": "20230130",
"SamplePackage": "N"
},
{
"NDCCode": "10337-395-30",
"PackageDescription": "1 TUBE in 1 CARTON (10337-395-30) > 30 g in 1 TUBE",
"NDC11Code": "10337-0395-30",
"ProductNDC": "10337-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apexicon E",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20021220",
"EndMarketingDate": "20230428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076263",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20021220",
"EndMarketingDatePackage": "20230428",
"SamplePackage": "N"
},
{
"NDCCode": "10337-395-66",
"PackageDescription": "6 TUBE in 1 CARTON (10337-395-66) > 2 g in 1 TUBE",
"NDC11Code": "10337-0395-66",
"ProductNDC": "10337-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apexicon E",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20021220",
"EndMarketingDate": "20230428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076263",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20021220",
"EndMarketingDatePackage": "20230130",
"SamplePackage": "N"
},
{
"NDCCode": "10337-163-60",
"PackageDescription": "1 TUBE in 1 CARTON (10337-163-60) > 60 g in 1 TUBE",
"NDC11Code": "10337-0163-60",
"ProductNDC": "10337-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temovate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074392",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19960930",
"SamplePackage": "N"
},
{
"NDCCode": "10337-301-60",
"PackageDescription": "1 TUBE in 1 CARTON (10337-301-60) > 60 g in 1 TUBE",
"NDC11Code": "10337-0301-60",
"ProductNDC": "10337-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temovate E",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075430",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "10337-332-60",
"PackageDescription": "60 g in 1 TUBE (10337-332-60)",
"NDC11Code": "10337-0332-60",
"ProductNDC": "10337-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cutivate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019958",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.",
"Description": "CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative."
},
{
"NDCCode": "10337-333-60",
"PackageDescription": "60 g in 1 TUBE (10337-333-60) ",
"NDC11Code": "10337-0333-60",
"ProductNDC": "10337-333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cutivate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019957",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19901214",
"SamplePackage": "N"
},
{
"NDCCode": "10337-358-60",
"PackageDescription": "1 TUBE in 1 CARTON (10337-358-60) > 60 g in 1 TUBE",
"NDC11Code": "10337-0358-60",
"ProductNDC": "10337-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019828",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "10337-359-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (10337-359-60) > 60 mL in 1 BOTTLE",
"NDC11Code": "10337-0359-60",
"ProductNDC": "10337-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020209",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19920930",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "10337-815-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (10337-815-06)",
"NDC11Code": "10337-0815-06",
"ProductNDC": "10337-815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adoxa",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065055",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections: 1 Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydia psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .",
"Description": "Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Doxycycline 150 mg capsules contain doxycycline monohydrate equivalent to 150 mg of doxycycline for oral administration. Inactive ingredients include colloidal silicon dioxide, FD&C Red #40, FD&C Yellow #6, gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide. Its molecular weight is 462.46. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form."
},
{
"NDCCode": "10544-395-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (10544-395-60)",
"NDC11Code": "10544-0395-60",
"ProductNDC": "10544-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040341",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "500; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-05-05"
},
{
"NDCCode": "11673-395-60",
"PackageDescription": "12 PACKET in 1 CARTON (11673-395-60) > 2.5 g in 1 PACKET",
"NDC11Code": "11673-0395-60",
"ProductNDC": "11673-395",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cocoa Butter, Phenylephrine Hydrochloride",
"NonProprietaryName": "Cocoa Butter, Phenylephrine Hydrochloride",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Target Corporation",
"SubstanceName": "COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "850; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "41250-395-60",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (41250-395-60) ",
"NDC11Code": "41250-0395-60",
"ProductNDC": "41250-395",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Lime/berry Antacid Chews",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Meijer",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Relieves : 1 Heartburn, 2 Sour stomach, 3 Acid indigestion, 4 Upset stomach due to these symptoms."
},
{
"NDCCode": "43063-395-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (43063-395-60) ",
"NDC11Code": "43063-0395-60",
"ProductNDC": "43063-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077918",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow Meloxicam Tablets contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam Tablets are available as tablets for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate."
},
{
"NDCCode": "47781-395-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-395-60) ",
"NDC11Code": "47781-0395-60",
"ProductNDC": "47781-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate",
"NonProprietaryName": "Hydrocodone Bitartrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208269",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210303",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Hydrocodone bitartrate extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Hydrocodone bitartrate is an opioid agonist. Its chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its structural formula is. Empirical formula: C18H21NO3 C4H6O6 2½H2O; Molecular weight: 494.49. Hydrocodone bitartrate exists as fine white crystals or a crystalline powder. It is affected by light. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform. The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg tablets contain the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyethylene oxide, polysorbate 80, polyvinyl alcohol, talc, and titanium dioxide. The 30 mg tablets also contain iron oxide red and iron oxide yellow. The 40 mg tablets also contain iron oxide red. The 60 mg tablets also contain FD&C Blue #2. The 80 mg tablets also contain D&C Red #27 and FD&C Blue #1. The 100 mg tablets also contain FD&C Blue #2 and iron oxide yellow. The 120 mg tablets also contain iron oxide yellow. The tablet imprinting ink contains ammonium hydroxide, butyl alcohol, iron oxide black, isopropyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "50663-395-00",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (50663-395-00) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50663-0395-00",
"ProductNDC": "50663-395",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zotos Professional Nutri For Women 2% Minoxidil Topical Solution",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "HENKEL US OPERATIONS CORPORATION",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230306",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "50742-395-60",
"PackageDescription": "12 POUCH in 1 CARTON (50742-395-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-395-05) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50742-0395-60",
"ProductNDC": "50742-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arformoterol Tartrate",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218156",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "Arformoterol tartrate inhalation solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) .",
"Description": "Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta 2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:. The molecular weight of arformoterol tartrateis 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4C 4H 6O 6(1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.9 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC ® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitroconditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
},
{
"NDCCode": "55700-395-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55700-395-60)",
"NDC11Code": "55700-0395-60",
"ProductNDC": "55700-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077870",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "58411-395-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-395-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0395-60",
"ProductNDC": "58411-395",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer",
"ProprietaryNameSuffix": "Broad Spectrum Spf 20 Sunscreen 2w1 Bisque",
"NonProprietaryName": "Avobenzone And Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101129",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "AVOBENZONE; OCTINOXATE",
"StrengthNumber": "1000; 3750",
"StrengthUnit": "mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20101129",
"SamplePackage": "N"
},
{
"NDCCode": "60429-395-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (60429-395-60) ",
"NDC11Code": "60429-0395-60",
"ProductNDC": "60429-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091072",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150310",
"SamplePackage": "N"
},
{
"NDCCode": "68180-395-07",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (68180-395-07) ",
"NDC11Code": "68180-0395-07",
"ProductNDC": "68180-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202240",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).",
"Description": "Celecoxib capsules is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib include: black iron oxide, croscarmellose sodium, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, propylene glycol, shellac, sodium lauryl sulphate, titanium dioxide, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "10337-358-30",
"PackageDescription": "1 TUBE in 1 CARTON (10337-358-30) > 30 g in 1 TUBE",
"NDC11Code": "10337-0358-30",
"ProductNDC": "10337-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019828",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "10337-358-42",
"PackageDescription": "2 g in 1 TUBE (10337-358-42) ",
"NDC11Code": "10337-0358-42",
"ProductNDC": "10337-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019828",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "10337-358-66",
"PackageDescription": "6 TUBE in 1 CARTON (10337-358-66) > 2 g in 1 TUBE",
"NDC11Code": "10337-0358-66",
"ProductNDC": "10337-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019828",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "10337-358-90",
"PackageDescription": "1 TUBE in 1 CARTON (10337-358-90) > 90 g in 1 TUBE",
"NDC11Code": "10337-0358-90",
"ProductNDC": "10337-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019828",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090819",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "10337-359-07",
"PackageDescription": "7 mL in 1 BOTTLE (10337-359-07) ",
"NDC11Code": "10337-0359-07",
"ProductNDC": "10337-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020209",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19920930",
"SamplePackage": "N",
"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020209",
"LabelerName": "PharmaDerm a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "OXICONAZOLE NITRATE",
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"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxistat",
"NonProprietaryName": "Oxiconazole Nitrate",
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"IndicationAndUsage": "OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.",
"Description": "OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative."
},
{
"NDCCode": "0093-3160-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0093-3160-06) ",
"NDC11Code": "00093-3160-06",
"ProductNDC": "0093-3160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065368",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below. C14H13N5O5S2 M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide."
}
]
}
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<Status>Deprecated</Status>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<PackageDescription>60 g in 1 TUBE (10337-332-60)</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cutivate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.</IndicationAndUsage>
<Description>CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative.</Description>
</NDC>
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<PackageDescription>60 g in 1 TUBE (10337-333-60) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cutivate</ProprietaryName>
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<DosageFormName>OINTMENT</DosageFormName>
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<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2021-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
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<NDC>
<NDCCode>10337-359-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (10337-359-60) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10337-0359-60</NDC11Code>
<ProductNDC>10337-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020209</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-815-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (10337-815-06)</PackageDescription>
<NDC11Code>10337-0815-06</NDC11Code>
<ProductNDC>10337-815</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adoxa</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065055</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections: 1 Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydia psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
<Description>Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Doxycycline 150 mg capsules contain doxycycline monohydrate equivalent to 150 mg of doxycycline for oral administration. Inactive ingredients include colloidal silicon dioxide, FD&C Red #40, FD&C Yellow #6, gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide. Its molecular weight is 462.46. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.</Description>
</NDC>
<NDC>
<NDCCode>10544-395-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (10544-395-60)</PackageDescription>
<NDC11Code>10544-0395-60</NDC11Code>
<ProductNDC>10544-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040341</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-05-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-395-60</NDCCode>
<PackageDescription>12 PACKET in 1 CARTON (11673-395-60) > 2.5 g in 1 PACKET</PackageDescription>
<NDC11Code>11673-0395-60</NDC11Code>
<ProductNDC>11673-395</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cocoa Butter, Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cocoa Butter, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41250-395-60</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (41250-395-60) </PackageDescription>
<NDC11Code>41250-0395-60</NDC11Code>
<ProductNDC>41250-395</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meijer Lime/berry Antacid Chews</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Meijer</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Relieves : 1 Heartburn, 2 Sour stomach, 3 Acid indigestion, 4 Upset stomach due to these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-395-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43063-395-60) </PackageDescription>
<NDC11Code>43063-0395-60</NDC11Code>
<ProductNDC>43063-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow Meloxicam Tablets contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam Tablets are available as tablets for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.</Description>
</NDC>
<NDC>
<NDCCode>47781-395-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-395-60) </PackageDescription>
<NDC11Code>47781-0395-60</NDC11Code>
<ProductNDC>47781-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208269</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydrocodone bitartrate extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Hydrocodone bitartrate is an opioid agonist. Its chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its structural formula is. Empirical formula: C18H21NO3 C4H6O6 2½H2O; Molecular weight: 494.49. Hydrocodone bitartrate exists as fine white crystals or a crystalline powder. It is affected by light. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform. The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg tablets contain the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyethylene oxide, polysorbate 80, polyvinyl alcohol, talc, and titanium dioxide. The 30 mg tablets also contain iron oxide red and iron oxide yellow. The 40 mg tablets also contain iron oxide red. The 60 mg tablets also contain FD&C Blue #2. The 80 mg tablets also contain D&C Red #27 and FD&C Blue #1. The 100 mg tablets also contain FD&C Blue #2 and iron oxide yellow. The 120 mg tablets also contain iron oxide yellow. The tablet imprinting ink contains ammonium hydroxide, butyl alcohol, iron oxide black, isopropyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>50663-395-00</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (50663-395-00) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50663-0395-00</NDC11Code>
<ProductNDC>50663-395</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zotos Professional Nutri For Women 2% Minoxidil Topical Solution</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>HENKEL US OPERATIONS CORPORATION</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50742-395-60</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (50742-395-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-395-05) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50742-0395-60</NDC11Code>
<ProductNDC>50742-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arformoterol Tartrate</ProprietaryName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218156</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arformoterol tartrate inhalation solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) .</IndicationAndUsage>
<Description>Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta 2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:. The molecular weight of arformoterol tartrateis 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4C 4H 6O 6(1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.9 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC ® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitroconditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).</Description>
</NDC>
<NDC>
<NDCCode>55700-395-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55700-395-60)</PackageDescription>
<NDC11Code>55700-0395-60</NDC11Code>
<ProductNDC>55700-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077870</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58411-395-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-395-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0395-60</NDC11Code>
<ProductNDC>58411-395</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 20 Sunscreen 2w1 Bisque</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone And Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>1000; 3750</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-395-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (60429-395-60) </PackageDescription>
<NDC11Code>60429-0395-60</NDC11Code>
<ProductNDC>60429-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091072</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-395-07</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68180-395-07) </PackageDescription>
<NDC11Code>68180-0395-07</NDC11Code>
<ProductNDC>68180-395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202240</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
<Description>Celecoxib capsules is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib include: black iron oxide, croscarmellose sodium, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, propylene glycol, shellac, sodium lauryl sulphate, titanium dioxide, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>10337-358-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10337-358-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>10337-0358-30</NDC11Code>
<ProductNDC>10337-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019828</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-358-42</NDCCode>
<PackageDescription>2 g in 1 TUBE (10337-358-42) </PackageDescription>
<NDC11Code>10337-0358-42</NDC11Code>
<ProductNDC>10337-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019828</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-358-66</NDCCode>
<PackageDescription>6 TUBE in 1 CARTON (10337-358-66) > 2 g in 1 TUBE</PackageDescription>
<NDC11Code>10337-0358-66</NDC11Code>
<ProductNDC>10337-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019828</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-358-90</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10337-358-90) > 90 g in 1 TUBE</PackageDescription>
<NDC11Code>10337-0358-90</NDC11Code>
<ProductNDC>10337-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019828</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-359-07</NDCCode>
<PackageDescription>7 mL in 1 BOTTLE (10337-359-07) </PackageDescription>
<NDC11Code>10337-0359-07</NDC11Code>
<ProductNDC>10337-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020209</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-359-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (10337-359-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10337-0359-30</NDC11Code>
<ProductNDC>10337-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020209</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10337-359-66</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (10337-359-66) > 7 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10337-0359-66</NDC11Code>
<ProductNDC>10337-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxistat</ProprietaryName>
<NonProprietaryName>Oxiconazole Nitrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020209</ApplicationNumber>
<LabelerName>PharmaDerm a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXISTAT® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES). OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.</IndicationAndUsage>
<Description>OXISTAT® (oxiconazole nitrate) Cream, 1% and OXISTAT® (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:. Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative. OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>0093-3160-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0093-3160-06) </PackageDescription>
<NDC11Code>00093-3160-06</NDC11Code>
<ProductNDC>0093-3160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065368</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below. C14H13N5O5S2 M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide.</Description>
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