{
"NDC": [
{
"NDCCode": "44523-607-01",
"PackageDescription": "30 g in 1 BOTTLE, PLASTIC (44523-607-01) ",
"NDC11Code": "44523-0607-01",
"ProductNDC": "44523-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110604",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110604",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "44523-607-02",
"PackageDescription": "60 g in 1 BOTTLE, PLASTIC (44523-607-02) ",
"NDC11Code": "44523-0607-02",
"ProductNDC": "44523-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110604",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110604",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "44523-053-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (44523-053-01) ",
"NDC11Code": "44523-0053-01",
"ProductNDC": "44523-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiopronin",
"NonProprietaryName": "Tiopronin",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019569",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "TIOPRONIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Tiopronin Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.",
"Description": "Tiopronin immediate-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Adverse reactions occurring at an incidence of ≥5% in an uncontrolled trial in 66 patients with cystinuria age 9 to 68 years are shown in the table below. Patients in group 1 had previously been treated with d-penicillamine; those in group 2 had not. Of those patients who had stopped taking d-penicillamine due to toxicity (34 out of 49 patients in group 1), 22 were able to continue treatment with Tiopronin Tablets. In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require Tiopronin Tablets withdrawal. Table 1 presents adverse reactions ≥5% in either treatment group occurring in this trial. Taste Disturbance A reduction in taste perception may develop. It is believed to be the result of chelation of trace metals by tiopronin. Hypogeusia is often self-limited. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Tablet contains 100 mg of tiopronin. The inactive ingredients in Tiopronin Tablets include calcium carbonate, carnauba wax, ethyl cellulose, dimethylaminoethyl methacrylate: butyl methacrylate: methyl methacrylate copolymer (Eudragit E 100), hydroxy-propyl cellulose, lactose monohydrate, magnesium stearate, povidone, sugar, talc, titanium dioxide."
},
{
"NDCCode": "44523-054-01",
"PackageDescription": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01) ",
"NDC11Code": "44523-0054-01",
"ProductNDC": "44523-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiopronin",
"NonProprietaryName": "Tiopronin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241205",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA211843",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "TIOPRONIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241205",
"SamplePackage": "N",
"IndicationAndUsage": "Tiopronin Delayed-Release Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.",
"Description": "Tiopronin Delayed-Release Tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Delayed-Release Tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in Tiopronin Delayed-Release Tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate."
},
{
"NDCCode": "44523-055-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01) ",
"NDC11Code": "44523-0055-01",
"ProductNDC": "44523-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiopronin",
"NonProprietaryName": "Tiopronin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241205",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA211843",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "TIOPRONIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241205",
"SamplePackage": "N",
"IndicationAndUsage": "Tiopronin Delayed-Release Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.",
"Description": "Tiopronin Delayed-Release Tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Delayed-Release Tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in Tiopronin Delayed-Release Tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate."
},
{
"NDCCode": "44523-156-01",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (44523-156-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "44523-0156-01",
"ProductNDC": "44523-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081271",
"LabelerName": "Bio Comp Pharma, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241209",
"SamplePackage": "N"
},
{
"NDCCode": "44523-410-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (44523-410-01) ",
"NDC11Code": "44523-0410-01",
"ProductNDC": "44523-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241203",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019071",
"LabelerName": "Biocomp Pharma, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241203",
"SamplePackage": "N",
"IndicationAndUsage": "1 INDICATIONS AND USAGE. 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones. Potassium Citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology. Potassium Citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones. Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].",
"Description": "Potassium Citrate is a citrate salt of potassium. Its empirical formula is K 3C 6H 50 7 H 20, and it has the following chemical structure:. Potassium Citrate yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate."
},
{
"NDCCode": "44523-415-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (44523-415-01) ",
"NDC11Code": "44523-0415-01",
"ProductNDC": "44523-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019071",
"LabelerName": "Biocomp Pharma, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "15",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131223",
"SamplePackage": "N",
"IndicationAndUsage": "1 INDICATIONS AND USAGE. 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones. Potassium Citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology. Potassium Citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones. Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].",
"Description": "Potassium Citrate is a citrate salt of potassium. Its empirical formula is K 3C 6H 50 7 H 20, and it has the following chemical structure:. Potassium Citrate yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate."
},
{
"NDCCode": "44523-602-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (44523-602-01) / 25 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "44523-0602-01",
"ProductNDC": "44523-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110430",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each mL contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "44523-603-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (44523-603-01) / 28 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "44523-0603-01",
"ProductNDC": "44523-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110430",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "44523-604-01",
"PackageDescription": "30 g in 1 BOTTLE, PLASTIC (44523-604-01) ",
"NDC11Code": "44523-0604-01",
"ProductNDC": "44523-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide, Sulfur",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110604",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110604",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "44523-617-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "44523-0617-01",
"ProductNDC": "44523-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "UREA",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.",
"Description": "Each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:."
},
{
"NDCCode": "44523-741-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (44523-741-01) ",
"NDC11Code": "44523-0741-01",
"ProductNDC": "44523-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyophen",
"NonProprietaryName": "Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100921",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "BENZOIC ACID; HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE",
"StrengthNumber": "9; .12; 81.6; 10.8; 36.2",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100921",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "44523-742-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (44523-742-01) ",
"NDC11Code": "44523-0742-01",
"ProductNDC": "44523-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phosphasal",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100921",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma",
"SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
"StrengthNumber": ".12; 81.6; 10.8; 36.2; 40.8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100921",
"SamplePackage": "N"
},
{
"NDCCode": "44523-743-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (44523-743-01) ",
"NDC11Code": "44523-0743-01",
"ProductNDC": "44523-743",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ustell",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190211",
"EndMarketingDate": "20231130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
"StrengthNumber": ".12; 120; 10; 36; 40.8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190211",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N"
},
{
"NDCCode": "44523-825-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "44523-0825-01",
"ProductNDC": "44523-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbinoxamine Maleate",
"NonProprietaryName": "Carbinoxamine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090756",
"LabelerName": "Biocomp Pharma, Inc.",
"SubstanceName": "CARBINOXAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210628",
"SamplePackage": "N",
"IndicationAndUsage": "Carbinoxamine maleate is effective for the symptomatic treatment of. Seasonal and perennial allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angio-edema. Dermatographism. As therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.",
"Description": "Carbinoxamine maleate is a histamine-H1 receptor blocking agent. Each tablet contains 4 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Carbinoxamine maleate is freely soluble in water. Its structure is. 2-[(4-chlorophenyl)-2-pyridinylmethoxy]- N, N- dimethylethanamine(Z)-2-butenedioate (1:1). C 16H 19CIN 2OC 4H 4O 4 MW=406.86."
},
{
"NDCCode": "10135-607-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (10135-607-01) ",
"NDC11Code": "10135-0607-01",
"ProductNDC": "10135-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171215",
"SamplePackage": "N",
"IndicationAndUsage": "For use as an adjunct in the therapy of all forms of Parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazine's).",
"Description": "Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1 α H, 5αH- tropane methane sulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, lactose monohydrate, lactose anhydrous, microcrystalline cellulose, cornstarch, talc and hydrogenated vegetable oil."
},
{
"NDCCode": "10812-607-01",
"PackageDescription": "30 mL in 1 BOTTLE (10812-607-01) ",
"NDC11Code": "10812-0607-01",
"ProductNDC": "10812-607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Shine Control Makeup",
"ProprietaryNameSuffix": "Broad Spectrum Spf20 - Warm Beige 90",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120326",
"EndMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "32",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120326",
"EndMarketingDatePackage": "20200530",
"SamplePackage": "N"
},
{
"NDCCode": "11410-607-01",
"PackageDescription": "4 g in 1 JAR (11410-607-01)",
"NDC11Code": "11410-0607-01",
"ProductNDC": "11410-607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sheer Cover Mineral Foundation",
"ProprietaryNameSuffix": "Spf-15 Nude",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/.1g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "13668-607-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (13668-607-01) ",
"NDC11Code": "13668-0607-01",
"ProductNDC": "13668-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212015",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200706",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets, USP and other antibacterial drugs, erythromycin tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin tablet, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin TM Lactobionate I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. 3. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. 3. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires’ Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease.",
"Description": "Erythromycin tablets, USP are an antibacterial product containing erythromycin, USP in a unique, nonenteric film coating for oral administration. Erythromycin tablets are available in two strengths containing 250 mg or 500 mg erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)- β-D- xylo–hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:."
},
{
"NDCCode": "23155-607-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-607-01) ",
"NDC11Code": "23155-0607-01",
"ProductNDC": "23155-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207201",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170227",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "47781-607-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-607-01) ",
"NDC11Code": "47781-0607-01",
"ProductNDC": "47781-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Disulfiram",
"NonProprietaryName": "Disulfiram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091681",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "DISULFIRAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49483-607-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49483-607-01) ",
"NDC11Code": "49483-0607-01",
"ProductNDC": "49483-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151230",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin Capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Capsules, USP contain 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue # 1 Aluminum Lake, propylene glycol, titanium dioxide and shellac."
},
{
"NDCCode": "49999-607-01",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (49999-607-01) ",
"NDC11Code": "49999-0607-01",
"ProductNDC": "49999-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074584",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100519",
"SamplePackage": "N"
},
{
"NDCCode": "50438-607-01",
"PackageDescription": "420 mL in 1 BOTTLE (50438-607-01)",
"NDC11Code": "50438-0607-01",
"ProductNDC": "50438-607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Essentials Dandruff",
"ProprietaryNameSuffix": "Dry Scalp",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150610",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Filo America",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Shake well, wet hair, massage onto scalp. Rinse, repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo."
},
{
"NDCCode": "50458-607-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-607-01) / 1 mL in 1 SYRINGE",
"NDC11Code": "50458-0607-01",
"ProductNDC": "50458-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Trinza",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20150519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207946",
"LabelerName": "Janssen Pharmaceuticals, Inc",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "410",
"StrengthUnit": "mg/1.32mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150519",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA TRINZA (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see Dosage and Administration (2.2)and Clinical Studies (14)] .",
"Description": "INVEGA TRINZA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA TRINZA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido [1,2- a] pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA TRINZA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in dose strengths of 273 mg, 410 mg, 546 mg, and 819 mg paliperidone palmitate in single-dose prefilled syringes. The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 175 mg, 263 mg, 350 mg, and 525 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (10 mg/mL), polyethylene glycol 4000 (75 mg/mL), citric acid monohydrate (7.5 mg/mL), sodium dihydrogen phosphate monohydrate (6 mg/mL), sodium hydroxide (5.4 mg/mL used as an alkalizing agent to set the pH at 7), and water for injection. INVEGA TRINZA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with either 175 mg (0.875 mL), 263 mg (1.315 mL), 350 mg (1.75 mL), or 525 mg (2.625 mL) paliperidone (as 273 mg, 410 mg, 546 mg, or 819 mg paliperidone palmitate) suspension with a plunger stopper and tip cap (bromobutyl rubber), a backstop, and 2 types of commercially available needles: a thin walled 22G, 1 ½-inch safety needle and a thin walled 22G, 1-inch safety needle."
},
{
"NDCCode": "51293-607-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (51293-607-01) ",
"NDC11Code": "51293-0607-01",
"ProductNDC": "51293-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride And Clidinium Bromide",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride And Clidinium Bromide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ECI Pharmaceuticals, LLC",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
"StrengthNumber": "5; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20110504",
"SamplePackage": "N",
"IndicationAndUsage": "Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows. \"Possibly\" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Final classification of the less-than-effective indications requires further investigation.",
"Description": "Chlordiazepoxide HCl and Clidinium Bromide combines in a single capsule formulation the antianxiety action of Chlordiazepoxide Hydrochloride and the anticholinergic/spasmolytic effects of Clidinium Bromide. Each Chlordiazepoxide HCl and Clidinium Bromide Capsule for oral administration contains 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide. Each capsule also contains D&C Yellow #10, FD&C Green #3, gelatin, lactose, starch, talc, and titanium dioxide. Chlordiazepoxide Hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide Hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1, 4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of Chlordiazepoxide Hydrochloride is as follows. Clidinium Bromide is 3-hydroxy-1-methylquinuclidinium bromide benzilate, a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally Clidinium Bromide is."
},
{
"NDCCode": "53489-607-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (53489-607-01)",
"NDC11Code": "53489-0607-01",
"ProductNDC": "53489-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077520",
"LabelerName": "Mutual Pharmaceutical Company, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principle metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β, 8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg, and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: butylated hydroxyanisole (BHA), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Additionally, lovastatin 10 mg contains pigment blend light orange, lovastatin 20 mg contains FD&C Blue #2 Aluminum Lake, and lovastatin 40 mg contains Lake blend green."
},
{
"NDCCode": "54860-607-01",
"PackageDescription": "2 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (54860-607-01) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "54860-0607-01",
"ProductNDC": "54860-607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Hand Sanitizers 2pk Cherry Blossom And French Vanilla",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260618",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260618",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product."
},
{
"NDCCode": "58602-607-01",
"PackageDescription": "1 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN",
"NDC11Code": "58602-0607-01",
"ProductNDC": "58602-607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Women)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (see pictures on side of this carton)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>44523-607-01</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PLASTIC (44523-607-01) </PackageDescription>
<NDC11Code>44523-0607-01</NDC11Code>
<ProductNDC>44523-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>44523-607-02</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PLASTIC (44523-607-02) </PackageDescription>
<NDC11Code>44523-0607-02</NDC11Code>
<ProductNDC>44523-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>44523-053-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (44523-053-01) </PackageDescription>
<NDC11Code>44523-0053-01</NDC11Code>
<ProductNDC>44523-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiopronin</ProprietaryName>
<NonProprietaryName>Tiopronin</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019569</ApplicationNumber>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>TIOPRONIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiopronin Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.</IndicationAndUsage>
<Description>Tiopronin immediate-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Adverse reactions occurring at an incidence of ≥5% in an uncontrolled trial in 66 patients with cystinuria age 9 to 68 years are shown in the table below. Patients in group 1 had previously been treated with d-penicillamine; those in group 2 had not. Of those patients who had stopped taking d-penicillamine due to toxicity (34 out of 49 patients in group 1), 22 were able to continue treatment with Tiopronin Tablets. In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require Tiopronin Tablets withdrawal. Table 1 presents adverse reactions ≥5% in either treatment group occurring in this trial. Taste Disturbance A reduction in taste perception may develop. It is believed to be the result of chelation of trace metals by tiopronin. Hypogeusia is often self-limited. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Tablet contains 100 mg of tiopronin. The inactive ingredients in Tiopronin Tablets include calcium carbonate, carnauba wax, ethyl cellulose, dimethylaminoethyl methacrylate: butyl methacrylate: methyl methacrylate copolymer (Eudragit E 100), hydroxy-propyl cellulose, lactose monohydrate, magnesium stearate, povidone, sugar, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>44523-054-01</NDCCode>
<PackageDescription>300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01) </PackageDescription>
<NDC11Code>44523-0054-01</NDC11Code>
<ProductNDC>44523-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiopronin</ProprietaryName>
<NonProprietaryName>Tiopronin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241205</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA211843</ApplicationNumber>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>TIOPRONIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiopronin Delayed-Release Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.</IndicationAndUsage>
<Description>Tiopronin Delayed-Release Tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Delayed-Release Tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in Tiopronin Delayed-Release Tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>44523-055-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01) </PackageDescription>
<NDC11Code>44523-0055-01</NDC11Code>
<ProductNDC>44523-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiopronin</ProprietaryName>
<NonProprietaryName>Tiopronin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241205</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA211843</ApplicationNumber>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>TIOPRONIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiopronin Delayed-Release Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.</IndicationAndUsage>
<Description>Tiopronin Delayed-Release Tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the empirical formula C 5H 9NO 3S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Delayed-Release Tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in Tiopronin Delayed-Release Tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>44523-156-01</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (44523-156-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>44523-0156-01</NDC11Code>
<ProductNDC>44523-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081271</ApplicationNumber>
<LabelerName>Bio Comp Pharma, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44523-410-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (44523-410-01) </PackageDescription>
<NDC11Code>44523-0410-01</NDC11Code>
<ProductNDC>44523-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241203</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019071</ApplicationNumber>
<LabelerName>Biocomp Pharma, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1 INDICATIONS AND USAGE. 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones. Potassium Citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology. Potassium Citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones. Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Potassium Citrate is a citrate salt of potassium. Its empirical formula is K 3C 6H 50 7 H 20, and it has the following chemical structure:. Potassium Citrate yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>44523-415-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (44523-415-01) </PackageDescription>
<NDC11Code>44523-0415-01</NDC11Code>
<ProductNDC>44523-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019071</ApplicationNumber>
<LabelerName>Biocomp Pharma, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1 INDICATIONS AND USAGE. 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones. Potassium Citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology. Potassium Citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones. Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Potassium Citrate is a citrate salt of potassium. Its empirical formula is K 3C 6H 50 7 H 20, and it has the following chemical structure:. Potassium Citrate yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>44523-602-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (44523-602-01) / 25 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>44523-0602-01</NDC11Code>
<ProductNDC>44523-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each mL contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>44523-603-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (44523-603-01) / 28 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>44523-0603-01</NDC11Code>
<ProductNDC>44523-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>44523-604-01</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PLASTIC (44523-604-01) </PackageDescription>
<NDC11Code>44523-0604-01</NDC11Code>
<ProductNDC>44523-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide, Sulfur</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>44523-617-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>44523-0617-01</NDC11Code>
<ProductNDC>44523-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
<Description>Each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:.</Description>
</NDC>
<NDC>
<NDCCode>44523-741-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (44523-741-01) </PackageDescription>
<NDC11Code>44523-0741-01</NDC11Code>
<ProductNDC>44523-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyophen</ProprietaryName>
<NonProprietaryName>Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100921</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>BENZOIC ACID; HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE</SubstanceName>
<StrengthNumber>9; .12; 81.6; 10.8; 36.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100921</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44523-742-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (44523-742-01) </PackageDescription>
<NDC11Code>44523-0742-01</NDC11Code>
<ProductNDC>44523-742</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phosphasal</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>.12; 81.6; 10.8; 36.2; 40.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44523-743-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (44523-743-01) </PackageDescription>
<NDC11Code>44523-0743-01</NDC11Code>
<ProductNDC>44523-743</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ustell</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<EndMarketingDate>20231130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>.12; 120; 10; 36; 40.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44523-825-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>44523-0825-01</NDC11Code>
<ProductNDC>44523-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbinoxamine Maleate</ProprietaryName>
<NonProprietaryName>Carbinoxamine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090756</ApplicationNumber>
<LabelerName>Biocomp Pharma, Inc.</LabelerName>
<SubstanceName>CARBINOXAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbinoxamine maleate is effective for the symptomatic treatment of. Seasonal and perennial allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angio-edema. Dermatographism. As therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.</IndicationAndUsage>
<Description>Carbinoxamine maleate is a histamine-H1 receptor blocking agent. Each tablet contains 4 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Carbinoxamine maleate is freely soluble in water. Its structure is. 2-[(4-chlorophenyl)-2-pyridinylmethoxy]- N, N- dimethylethanamine(Z)-2-butenedioate (1:1). C 16H 19CIN 2OC 4H 4O 4 MW=406.86.</Description>
</NDC>
<NDC>
<NDCCode>10135-607-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (10135-607-01) </PackageDescription>
<NDC11Code>10135-0607-01</NDC11Code>
<ProductNDC>10135-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090168</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as an adjunct in the therapy of all forms of Parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazine's).</IndicationAndUsage>
<Description>Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1 α H, 5αH- tropane methane sulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, lactose monohydrate, lactose anhydrous, microcrystalline cellulose, cornstarch, talc and hydrogenated vegetable oil.</Description>
</NDC>
<NDC>
<NDCCode>10812-607-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (10812-607-01) </PackageDescription>
<NDC11Code>10812-0607-01</NDC11Code>
<ProductNDC>10812-607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Shine Control Makeup</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf20 - Warm Beige 90</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<EndMarketingDate>20200530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>32</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120326</StartMarketingDatePackage>
<EndMarketingDatePackage>20200530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11410-607-01</NDCCode>
<PackageDescription>4 g in 1 JAR (11410-607-01)</PackageDescription>
<NDC11Code>11410-0607-01</NDC11Code>
<ProductNDC>11410-607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sheer Cover Mineral Foundation</ProprietaryName>
<ProprietaryNameSuffix>Spf-15 Nude</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.1g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>13668-607-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (13668-607-01) </PackageDescription>
<NDC11Code>13668-0607-01</NDC11Code>
<ProductNDC>13668-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212015</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets, USP and other antibacterial drugs, erythromycin tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin tablet, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin TM Lactobionate I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. 3. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. 3. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires’ Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease.</IndicationAndUsage>
<Description>Erythromycin tablets, USP are an antibacterial product containing erythromycin, USP in a unique, nonenteric film coating for oral administration. Erythromycin tablets are available in two strengths containing 250 mg or 500 mg erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)- β-D- xylo–hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>23155-607-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (23155-607-01) </PackageDescription>
<NDC11Code>23155-0607-01</NDC11Code>
<ProductNDC>23155-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207201</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>47781-607-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-607-01) </PackageDescription>
<NDC11Code>47781-0607-01</NDC11Code>
<ProductNDC>47781-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Disulfiram</ProprietaryName>
<NonProprietaryName>Disulfiram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091681</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>DISULFIRAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49483-607-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (49483-607-01) </PackageDescription>
<NDC11Code>49483-0607-01</NDC11Code>
<ProductNDC>49483-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090007</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin Capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Capsules, USP contain 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue # 1 Aluminum Lake, propylene glycol, titanium dioxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>49999-607-01</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (49999-607-01) </PackageDescription>
<NDC11Code>49999-0607-01</NDC11Code>
<ProductNDC>49999-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074584</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50438-607-01</NDCCode>
<PackageDescription>420 mL in 1 BOTTLE (50438-607-01)</PackageDescription>
<NDC11Code>50438-0607-01</NDC11Code>
<ProductNDC>50438-607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basic Essentials Dandruff</ProprietaryName>
<ProprietaryNameSuffix>Dry Scalp</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Filo America</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Shake well, wet hair, massage onto scalp. Rinse, repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50458-607-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 KIT (50458-607-01) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50458-0607-01</NDC11Code>
<ProductNDC>50458-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invega Trinza</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207946</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>410</StrengthNumber>
<StrengthUnit>mg/1.32mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVEGA TRINZA (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see Dosage and Administration (2.2)and Clinical Studies (14)] .</IndicationAndUsage>
<Description>INVEGA TRINZA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA TRINZA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido [1,2- a] pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA TRINZA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in dose strengths of 273 mg, 410 mg, 546 mg, and 819 mg paliperidone palmitate in single-dose prefilled syringes. The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 175 mg, 263 mg, 350 mg, and 525 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (10 mg/mL), polyethylene glycol 4000 (75 mg/mL), citric acid monohydrate (7.5 mg/mL), sodium dihydrogen phosphate monohydrate (6 mg/mL), sodium hydroxide (5.4 mg/mL used as an alkalizing agent to set the pH at 7), and water for injection. INVEGA TRINZA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with either 175 mg (0.875 mL), 263 mg (1.315 mL), 350 mg (1.75 mL), or 525 mg (2.625 mL) paliperidone (as 273 mg, 410 mg, 546 mg, or 819 mg paliperidone palmitate) suspension with a plunger stopper and tip cap (bromobutyl rubber), a backstop, and 2 types of commercially available needles: a thin walled 22G, 1 ½-inch safety needle and a thin walled 22G, 1-inch safety needle.</Description>
</NDC>
<NDC>
<NDCCode>51293-607-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (51293-607-01) </PackageDescription>
<NDC11Code>51293-0607-01</NDC11Code>
<ProductNDC>51293-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ECI Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows. "Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Final classification of the less-than-effective indications requires further investigation.</IndicationAndUsage>
<Description>Chlordiazepoxide HCl and Clidinium Bromide combines in a single capsule formulation the antianxiety action of Chlordiazepoxide Hydrochloride and the anticholinergic/spasmolytic effects of Clidinium Bromide. Each Chlordiazepoxide HCl and Clidinium Bromide Capsule for oral administration contains 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide. Each capsule also contains D&C Yellow #10, FD&C Green #3, gelatin, lactose, starch, talc, and titanium dioxide. Chlordiazepoxide Hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide Hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1, 4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of Chlordiazepoxide Hydrochloride is as follows. Clidinium Bromide is 3-hydroxy-1-methylquinuclidinium bromide benzilate, a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally Clidinium Bromide is.</Description>
</NDC>
<NDC>
<NDCCode>53489-607-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (53489-607-01)</PackageDescription>
<NDC11Code>53489-0607-01</NDC11Code>
<ProductNDC>53489-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077520</ApplicationNumber>
<LabelerName>Mutual Pharmaceutical Company, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principle metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β, 8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg, and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: butylated hydroxyanisole (BHA), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Additionally, lovastatin 10 mg contains pigment blend light orange, lovastatin 20 mg contains FD&C Blue #2 Aluminum Lake, and lovastatin 40 mg contains Lake blend green.</Description>
</NDC>
<NDC>
<NDCCode>54860-607-01</NDCCode>
<PackageDescription>2 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (54860-607-01) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>54860-0607-01</NDC11Code>
<ProductNDC>54860-607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Hand Sanitizers 2pk Cherry Blossom And French Vanilla</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-607-01</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>58602-0607-01</NDC11Code>
<ProductNDC>58602-607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Women)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (see pictures on side of this carton).</IndicationAndUsage>
</NDC>
</NDCList>