{
"NDC": [
{
"NDCCode": "54766-770-40",
"PackageDescription": "1 TUBE in 1 CARTON (54766-770-40) / 40 g in 1 TUBE",
"NDC11Code": "54766-0770-40",
"ProductNDC": "54766-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naftin",
"NonProprietaryName": "Naftifine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180122",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019356",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "NAFTIFINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180122",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans * Efficacy for this organism in this organ system was studied in fewer than 10 infections., Epidermophyton floccosum * .",
"Description": "Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only."
},
{
"NDCCode": "54766-770-60",
"PackageDescription": "1 TUBE in 1 CARTON (54766-770-60) / 60 g in 1 TUBE",
"NDC11Code": "54766-0770-60",
"ProductNDC": "54766-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naftin",
"NonProprietaryName": "Naftifine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180122",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019356",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "NAFTIFINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180122",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans * Efficacy for this organism in this organ system was studied in fewer than 10 infections., Epidermophyton floccosum * .",
"Description": "Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only."
},
{
"NDCCode": "54766-770-90",
"PackageDescription": "1 TUBE in 1 CARTON (54766-770-90) / 90 g in 1 TUBE",
"NDC11Code": "54766-0770-90",
"ProductNDC": "54766-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naftin",
"NonProprietaryName": "Naftifine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180122",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019356",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "NAFTIFINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180122",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans * Efficacy for this organism in this organ system was studied in fewer than 10 infections., Epidermophyton floccosum * .",
"Description": "Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only."
},
{
"NDCCode": "60760-770-40",
"PackageDescription": "40 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-770-40) ",
"NDC11Code": "60760-0770-40",
"ProductNDC": "60760-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181115",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "69423-770-40",
"PackageDescription": "3 CARTON in 1 CELLO PACK (69423-770-40) / 1 TUBE in 1 CARTON / 107 g in 1 TUBE",
"NDC11Code": "69423-0770-40",
"ProductNDC": "69423-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest 3d White",
"ProprietaryNameSuffix": "Advanced Radiant Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20201011",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201011",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "54766-093-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (54766-093-06) ",
"NDC11Code": "54766-0093-06",
"ProductNDC": "54766-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ridaura",
"NonProprietaryName": "Auranofin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20161215",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018689",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "AURANOFIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161215",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage. In controlled clinical trials comparing RIDAURA with injectable gold, RIDAURA was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of RIDAURA in patients who are candidates for chrysotherapy.",
"Description": "RIDAURA (auranofin) is available in oral form as capsules containing 3 mg auranofin. Auranofin is (2,3,4,6-tetra-O-acetyl-1-thio-ß-D-glucopyranosato-S-) (triethyl–phosphine) gold. Auranofin contains 29% gold and has the following chemical structure. Each RIDAURA capsule, with opaque brown cap and opaque tan body, contains auranofin, 3 mg, and is imprinted with the product name RIDAURA. Inactive ingredients consist of benzyl alcohol, cellulose, cetylpyridinium chloride, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients."
},
{
"NDCCode": "54766-201-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54766-201-01) ",
"NDC11Code": "54766-0201-01",
"ProductNDC": "54766-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pexeva",
"NonProprietaryName": "Paroxetine Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021299",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE MESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170602",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).",
"Description": "PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only)."
},
{
"NDCCode": "54766-202-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54766-202-01) ",
"NDC11Code": "54766-0202-01",
"ProductNDC": "54766-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pexeva",
"NonProprietaryName": "Paroxetine Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021299",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE MESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170602",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).",
"Description": "PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only)."
},
{
"NDCCode": "54766-203-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54766-203-01) ",
"NDC11Code": "54766-0203-01",
"ProductNDC": "54766-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pexeva",
"NonProprietaryName": "Paroxetine Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021299",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE MESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170602",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).",
"Description": "PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only)."
},
{
"NDCCode": "54766-204-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54766-204-01) ",
"NDC11Code": "54766-0204-01",
"ProductNDC": "54766-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pexeva",
"NonProprietaryName": "Paroxetine Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021299",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE MESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170602",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).",
"Description": "PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only)."
},
{
"NDCCode": "54766-716-03",
"PackageDescription": "57 g in 1 TUBE (54766-716-03) ",
"NDC11Code": "54766-0716-03",
"ProductNDC": "54766-716",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone Cream",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150804",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085368",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150804",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-716-04",
"PackageDescription": "28.4 g in 1 TUBE (54766-716-04) ",
"NDC11Code": "54766-0716-04",
"ProductNDC": "54766-716",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone Cream",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150804",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085368",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150804",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-726-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (54766-726-04) ",
"NDC11Code": "54766-0726-04",
"ProductNDC": "54766-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141016",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085979",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150807",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below."
},
{
"NDCCode": "54766-726-06",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (54766-726-06) ",
"NDC11Code": "54766-0726-06",
"ProductNDC": "54766-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141016",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085979",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150807",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below."
},
{
"NDCCode": "54766-729-04",
"PackageDescription": "118 mL in 1 BOTTLE (54766-729-04) ",
"NDC11Code": "54766-0729-04",
"ProductNDC": "54766-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150702",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085980",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150702",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-729-06",
"PackageDescription": "59 mL in 1 BOTTLE (54766-729-06) ",
"NDC11Code": "54766-0729-06",
"ProductNDC": "54766-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085980",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150702",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-760-03",
"PackageDescription": "57 g in 1 TUBE (54766-760-03) ",
"NDC11Code": "54766-0760-03",
"ProductNDC": "54766-760",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150414",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-760-04",
"PackageDescription": "28.4 g in 1 TUBE (54766-760-04) ",
"NDC11Code": "54766-0760-04",
"ProductNDC": "54766-760",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramosone",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150414",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Pramosone® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-778-04",
"PackageDescription": "28.4 g in 1 TUBE, WITH APPLICATOR (54766-778-04) ",
"NDC11Code": "54766-0778-04",
"ProductNDC": "54766-778",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150805",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085368",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150805",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Analpram HC ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3,HCl: mol. wt: 329.87."
},
{
"NDCCode": "54766-799-04",
"PackageDescription": "28.4 g in 1 TUBE, WITH APPLICATOR (54766-799-04) ",
"NDC11Code": "54766-0799-04",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150807",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-799-64",
"PackageDescription": "30 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-64) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) ",
"NDC11Code": "54766-0799-64",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150807",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-799-65",
"PackageDescription": "12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-65) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) ",
"NDC11Code": "54766-0799-65",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150807",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-799-71",
"PackageDescription": "30 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-71) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) ",
"NDC11Code": "54766-0799-71",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150807",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-799-72",
"PackageDescription": "12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-72) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) ",
"NDC11Code": "54766-0799-72",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150807",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-829-04",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (54766-829-04) ",
"NDC11Code": "54766-0829-04",
"ProductNDC": "54766-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150805",
"EndMarketingDate": "20270328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085979",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150805",
"EndMarketingDatePackage": "20270328",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Analpram HC ® Lotion 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl ; mol. wt.: 329.87."
},
{
"NDCCode": "0067-6280-26",
"PackageDescription": "770 mL in 1 BOTTLE (0067-6280-26)",
"NDC11Code": "00067-6280-26",
"ProductNDC": "0067-6280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maalox",
"ProprietaryNameSuffix": "Advanced Maximum Strength Cherry",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide,simethicone",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Novartis Consumer Health, Inc",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "400; 400; 40",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10135-770-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10135-770-90) ",
"NDC11Code": "10135-0770-90",
"ProductNDC": "10135-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205347",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"Description": "Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal anhydrous silica, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide and iron oxides (yellow, black and/or red)."
},
{
"NDCCode": "16571-770-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-770-09) ",
"NDC11Code": "16571-0770-09",
"ProductNDC": "16571-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091163",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110330",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
},
{
"NDCCode": "16571-770-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-770-10) ",
"NDC11Code": "16571-0770-10",
"ProductNDC": "16571-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091163",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110330",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
},
{
"NDCCode": "21695-770-01",
"PackageDescription": "1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "21695-0770-01",
"ProductNDC": "21695-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20110125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075808",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.",
"Description": "Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54766-770-40</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (54766-770-40) / 40 g in 1 TUBE</PackageDescription>
<NDC11Code>54766-0770-40</NDC11Code>
<ProductNDC>54766-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naftin</ProprietaryName>
<NonProprietaryName>Naftifine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180122</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019356</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NAFTIFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180122</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans * Efficacy for this organism in this organ system was studied in fewer than 10 infections., Epidermophyton floccosum * .</IndicationAndUsage>
<Description>Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>54766-770-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (54766-770-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>54766-0770-60</NDC11Code>
<ProductNDC>54766-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naftin</ProprietaryName>
<NonProprietaryName>Naftifine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180122</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019356</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NAFTIFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180122</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans * Efficacy for this organism in this organ system was studied in fewer than 10 infections., Epidermophyton floccosum * .</IndicationAndUsage>
<Description>Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>54766-770-90</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (54766-770-90) / 90 g in 1 TUBE</PackageDescription>
<NDC11Code>54766-0770-90</NDC11Code>
<ProductNDC>54766-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naftin</ProprietaryName>
<NonProprietaryName>Naftifine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180122</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019356</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NAFTIFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180122</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans * Efficacy for this organism in this organ system was studied in fewer than 10 infections., Epidermophyton floccosum * .</IndicationAndUsage>
<Description>Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only.</Description>
</NDC>
<NDC>
<NDCCode>60760-770-40</NDCCode>
<PackageDescription>40 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-770-40) </PackageDescription>
<NDC11Code>60760-0770-40</NDC11Code>
<ProductNDC>60760-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209312</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69423-770-40</NDCCode>
<PackageDescription>3 CARTON in 1 CELLO PACK (69423-770-40) / 1 TUBE in 1 CARTON / 107 g in 1 TUBE</PackageDescription>
<NDC11Code>69423-0770-40</NDC11Code>
<ProductNDC>69423-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest 3d White</ProprietaryName>
<ProprietaryNameSuffix>Advanced Radiant Mint</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20201011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54766-093-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (54766-093-06) </PackageDescription>
<NDC11Code>54766-0093-06</NDC11Code>
<ProductNDC>54766-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ridaura</ProprietaryName>
<NonProprietaryName>Auranofin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018689</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AURANOFIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage. In controlled clinical trials comparing RIDAURA with injectable gold, RIDAURA was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of RIDAURA in patients who are candidates for chrysotherapy.</IndicationAndUsage>
<Description>RIDAURA (auranofin) is available in oral form as capsules containing 3 mg auranofin. Auranofin is (2,3,4,6-tetra-O-acetyl-1-thio-ß-D-glucopyranosato-S-) (triethyl–phosphine) gold. Auranofin contains 29% gold and has the following chemical structure. Each RIDAURA capsule, with opaque brown cap and opaque tan body, contains auranofin, 3 mg, and is imprinted with the product name RIDAURA. Inactive ingredients consist of benzyl alcohol, cellulose, cetylpyridinium chloride, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>54766-201-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54766-201-01) </PackageDescription>
<NDC11Code>54766-0201-01</NDC11Code>
<ProductNDC>54766-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pexeva</ProprietaryName>
<NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021299</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE MESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).</IndicationAndUsage>
<Description>PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).</Description>
</NDC>
<NDC>
<NDCCode>54766-202-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54766-202-01) </PackageDescription>
<NDC11Code>54766-0202-01</NDC11Code>
<ProductNDC>54766-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pexeva</ProprietaryName>
<NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021299</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE MESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).</IndicationAndUsage>
<Description>PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).</Description>
</NDC>
<NDC>
<NDCCode>54766-203-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54766-203-01) </PackageDescription>
<NDC11Code>54766-0203-01</NDC11Code>
<ProductNDC>54766-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pexeva</ProprietaryName>
<NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021299</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE MESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).</IndicationAndUsage>
<Description>PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).</Description>
</NDC>
<NDC>
<NDCCode>54766-204-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54766-204-01) </PackageDescription>
<NDC11Code>54766-0204-01</NDC11Code>
<ProductNDC>54766-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pexeva</ProprietaryName>
<NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021299</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE MESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEXEVA is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Generalized anxiety disorder (GAD).</IndicationAndUsage>
<Description>PEXEVA contains paroxetine mesylate, an SSRI. It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C 19H 20FNO 3CH 3SO 3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:. Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water. PEXEVA tablets are intended for oral administration. Each oval, film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg paroxetine equivalent to 12.9 mg, 25.8 mg, 38.8 mg, or 51.7 mg paroxetine mesylate, respectively. Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).</Description>
</NDC>
<NDC>
<NDCCode>54766-716-03</NDCCode>
<PackageDescription>57 g in 1 TUBE (54766-716-03) </PackageDescription>
<NDC11Code>54766-0716-03</NDC11Code>
<ProductNDC>54766-716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramosone Cream</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150804</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085368</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150804</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
</NDC>
<NDC>
<NDCCode>54766-716-04</NDCCode>
<PackageDescription>28.4 g in 1 TUBE (54766-716-04) </PackageDescription>
<NDC11Code>54766-0716-04</NDC11Code>
<ProductNDC>54766-716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramosone Cream</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150804</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085368</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150804</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
</NDC>
<NDC>
<NDCCode>54766-726-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (54766-726-04) </PackageDescription>
<NDC11Code>54766-0726-04</NDC11Code>
<ProductNDC>54766-726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramosone</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141016</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085979</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.</Description>
</NDC>
<NDC>
<NDCCode>54766-726-06</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, PLASTIC (54766-726-06) </PackageDescription>
<NDC11Code>54766-0726-06</NDC11Code>
<ProductNDC>54766-726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramosone</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141016</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085979</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.</Description>
</NDC>
<NDC>
<NDCCode>54766-729-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (54766-729-04) </PackageDescription>
<NDC11Code>54766-0729-04</NDC11Code>
<ProductNDC>54766-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramosone</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150702</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085980</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150702</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
</NDC>
<NDC>
<NDCCode>54766-729-06</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (54766-729-06) </PackageDescription>
<NDC11Code>54766-0729-06</NDC11Code>
<ProductNDC>54766-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramosone</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085980</ApplicationNumber>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150702</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150414</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<PackageDescription>28.4 g in 1 TUBE (54766-760-04) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Pramosone® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol.wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<ProductNDC>54766-778</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Analpram Hc</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150805</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085368</ApplicationNumber>
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<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150805</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Analpram HC ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3,HCl: mol. wt: 329.87.</Description>
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<ProductNDC>54766-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150807</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
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<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<ProductNDC>54766-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<StartMarketingDate>20150807</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
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<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<EndMarketingDate>20270328</EndMarketingDate>
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<ApplicationNumber>ANDA085979</ApplicationNumber>
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<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150805</StartMarketingDatePackage>
<EndMarketingDatePackage>20270328</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Analpram HC ® Lotion 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl ; mol. wt.: 329.87.</Description>
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<ProprietaryNameSuffix>Advanced Maximum Strength Cherry</ProprietaryNameSuffix>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Novartis Consumer Health, Inc</LabelerName>
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<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<ProductNDC>10135-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205347</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal anhydrous silica, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide and iron oxides (yellow, black and/or red).</Description>
</NDC>
<NDC>
<NDCCode>16571-770-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-770-09) </PackageDescription>
<NDC11Code>16571-0770-09</NDC11Code>
<ProductNDC>16571-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091163</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>16571-770-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-770-10) </PackageDescription>
<NDC11Code>16571-0770-10</NDC11Code>
<ProductNDC>16571-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091163</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>21695-770-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0770-01</NDC11Code>
<ProductNDC>21695-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075808</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.</IndicationAndUsage>
<Description>Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows.</Description>
</NDC>
</NDCList>