{
"NDC": [
{
"NDCCode": "72162-2175-6",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72162-2175-6) ",
"NDC11Code": "72162-2175-06",
"ProductNDC": "72162-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205129",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231207",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake."
},
{
"NDCCode": "55154-2175-4",
"PackageDescription": "100 POUCH in 1 CARTON (55154-2175-4) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (55154-2175-6)",
"NDC11Code": "55154-2175-04",
"ProductNDC": "55154-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "Cardinal Health",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62991-2175-6",
"PackageDescription": "5 g in 1 JAR (62991-2175-6)",
"NDC11Code": "62991-2175-06",
"ProductNDC": "62991-2175",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Triamcinolone Diacetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111104",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "TRIAMCINOLONE DIACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "72162-2175-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72162-2175-3) ",
"NDC11Code": "72162-2175-03",
"ProductNDC": "72162-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205129",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231207",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake."
},
{
"NDCCode": "72162-2175-5",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (72162-2175-5) ",
"NDC11Code": "72162-2175-05",
"ProductNDC": "72162-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205129",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231207",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake."
},
{
"NDCCode": "43742-2175-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (43742-2175-1) ",
"NDC11Code": "43742-2175-01",
"ProductNDC": "43742-2175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Liver Drainage",
"NonProprietaryName": "Berberis Vulgaris, Carbolicum Acidum, Carduus Marianus, Chelidonium Majus, Chromium Picolinate, Cichorium Intybus, Flos, Cobalt Gluconate, Copper Gluconate, Gallbladder (suis), Hepar Suis, Magnesium Gluconicum Dihydricum, Natrum Sulphuricum, Nux Vomica, Pancreas Suis, Picrorhiza Kurroa, Ptelea Trifoliate, Raphanus Sativus, Sarcolacticum Acidum, Schisandra Chinensis, Sulphur, Taraxacum Officinale, Vanadium Metallicum, Verbena Officinalis, Flos, Viscum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240529",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; PHENOL; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; CHROMIUM PICOLINATE; CICHORIUM INTYBUS FLOWER; COBALTOUS GLUCONATE; COPPER GLUCONATE; SUS SCROFA GALLBLADDER; PORK LIVER; MAGNESIUM GLUCONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; PICRORHIZA KURROA WHOLE; PTELEA TRIFOLIATA BARK; RADISH; LACTIC ACID, L-; SCHISANDRA CHINENSIS FRUIT; SULFUR; TARAXACUM OFFICINALE; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 8; 2; 1; 6; 8; 6; 6; 8; 8; 6; 6; 8; 8; 10; 6; 3; 6; 2; 6; 2; 8; 8; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240529",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of symptoms including. liver discomfort poor digestion low energy. alternating occasional diarrhea and constipation. These statements are based upon homeopathic practices. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "50090-2175-0",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-2175-0) ",
"NDC11Code": "50090-2175-00",
"ProductNDC": "50090-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .",
"Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
},
{
"NDCCode": "50090-2175-1",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (50090-2175-1) ",
"NDC11Code": "50090-2175-01",
"ProductNDC": "50090-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .",
"Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
},
{
"NDCCode": "50090-2175-2",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50090-2175-2) ",
"NDC11Code": "50090-2175-02",
"ProductNDC": "50090-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .",
"Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
},
{
"NDCCode": "50090-2175-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2175-3) ",
"NDC11Code": "50090-2175-03",
"ProductNDC": "50090-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .",
"Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
},
{
"NDCCode": "50090-2175-4",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-2175-4) ",
"NDC11Code": "50090-2175-04",
"ProductNDC": "50090-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .",
"Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
},
{
"NDCCode": "63083-2175-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2175-2) ",
"NDC11Code": "63083-2175-02",
"ProductNDC": "63083-2175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rehydration Drops",
"ProprietaryNameSuffix": "2175",
"NonProprietaryName": "Rehydration Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "ARABICA COFFEE BEAN; TARAXACUM OFFICINALE; HYPERICUM PERFORATUM WHOLE; ADENOSINE TRIPHOSPHATE; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BEEF KIDNEY; .GAMMA.-AMINOBUTYRIC ACID; GERMANIUM; SEROTONIN",
"StrengthNumber": "1; 1; 3; 4; 4; 6; 6; 6; 6; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63629-2175-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2175-1) ",
"NDC11Code": "63629-2175-01",
"ProductNDC": "63629-2175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078992",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131119",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate Hydrochloride Extended-release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] .",
"Description": "Dexmethylphenidate Hydrochloride Extended-release Capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threoenantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate Hydrochloride Extended-release Capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate Hydrochloride Extended-release Capsules is intended for oral administration and is available as 15 mg and 30 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is:. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients:sugar spheres, methacrylic acid copolymers, triethyl citrate, talc, colloidal silicon dioxide, Hypromellose, polydextrose, triacetin, macrogol/PEG, FD&C Yellow #6/Sunset Yellow FCF AL, FD&C Blue #2/ indigo carmine AL, titanium dioxide and gelatin."
},
{
"NDCCode": "72162-1051-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (72162-1051-6) ",
"NDC11Code": "72162-1051-06",
"ProductNDC": "72162-1051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaprozin",
"NonProprietaryName": "Oxaprozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010131",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075845",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXAPROZIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240716",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaprozin tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For relief of the signs and symptoms of juvenile rheumatoid arthritis.",
"Description": "Oxaprozin tablets, USP are a nonsteroidal anti-inflammatory drug, available as tablets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293. Its molecular formula is C18H15NO3, and it has the following chemical structure. Oxaprozin, USP is a white to off-white powder with a slight odor and a melting point of 162°C to 163°C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4). The pKa in water is 4.3. Oxaprozin tablets, USP contain 600 mg of oxaprozin, USP. In addition, each tablet of oxaprozin, USP contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, hypromellose, methylcellulose, magnesium stearate, polacrilin potassium, starch, polyethylene glycol, titanium dioxide, and polysorbate 80."
},
{
"NDCCode": "72162-1059-6",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-6) ",
"NDC11Code": "72162-1059-06",
"ProductNDC": "72162-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078056",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"Description": "Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2."
},
{
"NDCCode": "72162-1080-6",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72162-1080-6) ",
"NDC11Code": "72162-1080-06",
"ProductNDC": "72162-1080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "72162-1081-6",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72162-1081-6) ",
"NDC11Code": "72162-1081-06",
"ProductNDC": "72162-1081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077471",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia."
},
{
"NDCCode": "72162-1082-6",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72162-1082-6) ",
"NDC11Code": "72162-1082-06",
"ProductNDC": "72162-1082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077471",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia."
},
{
"NDCCode": "72162-1084-6",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72162-1084-6) ",
"NDC11Code": "72162-1084-06",
"ProductNDC": "72162-1084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20111209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201407",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "37.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230509",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.",
"Description": "Each triamterene and hydrochlorothiazide capsule for oral use contains triamterene 37.5 mg and hydrochlorothiazide 25 mg. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent. Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. Molecular Formula: C7H8CIN3O4S2 M.W. 297.74. At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene is 2,4,7-triamino-6-phenylpteridine and its structural formula is. Molecular Formula: C12H11N7 M.W. 253.26. Inactive ingredients consist of lactose monohydrate, pregelatinized starch, sodium starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and magnesium stearate. The capsule shell consists of titanium dioxide and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules."
},
{
"NDCCode": "72162-1108-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72162-1108-6) ",
"NDC11Code": "72162-1108-06",
"ProductNDC": "72162-1108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091573",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231009",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium Chloride Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium chloride is a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g per 2 mL. Each Trospium Chloride Tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, povidone, hypromellose, talc, stearic acid, titanium dioxide, colloidal silicon dioxide, magnesium stearate and polyethylene glycol 3350."
},
{
"NDCCode": "72162-1124-6",
"PackageDescription": "60 g in 1 BOTTLE, PLASTIC (72162-1124-6) ",
"NDC11Code": "72162-1124-06",
"ProductNDC": "72162-1124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystop",
"NonProprietaryName": "Nystatin",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064118",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc."
},
{
"NDCCode": "72162-1270-6",
"PackageDescription": "1 BOTTLE in 1 CARTON (72162-1270-6) / 60 mL in 1 BOTTLE",
"NDC11Code": "72162-1270-06",
"ProductNDC": "72162-1270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide Topical Solution Usp, 0.05%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209699",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190419",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide topical solution, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide topical solution, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a clear transparent solution of ethyl alcohol (35%),citric acid monohydrate,diisopropyl adipate, propylene glycol and purified water."
},
{
"NDCCode": "72162-1271-6",
"PackageDescription": "1 BOTTLE in 1 CARTON (72162-1271-6) / 60 mL in 1 BOTTLE",
"NDC11Code": "72162-1271-06",
"ProductNDC": "72162-1271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide Topical Solution Usp, 0.01%",
"NonProprietaryName": "Fluocinolone Acetonide Topical Solution Usp, 0.01%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209913",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190320",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Topical Solution, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1, 4-diene-3, 20-dione, 6, 9-difluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis (oxy)]-, (6α, 11β, 16α)-. It has the following chemical structure. Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of anhydrous citric acid and propylene glycol."
},
{
"NDCCode": "72162-1272-6",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1272-6) / 60 g in 1 TUBE",
"NDC11Code": "72162-1272-06",
"ProductNDC": "72162-1272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide Ointment, 0.05%",
"NonProprietaryName": "Desonide Ointment, 0.05%",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210998",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190320",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is white to off-white powder. The solubility of desonide in distilled water saturated with the ether is 184 mg/L.Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum."
},
{
"NDCCode": "72162-1273-6",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1273-6) / 60 g in 1 TUBE",
"NDC11Code": "72162-1273-06",
"ProductNDC": "72162-1273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate Ointment Usp, 0.05%",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211295",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230926",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "72162-1275-6",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1275-6) / 60 g in 1 TUBE",
"NDC11Code": "72162-1275-06",
"ProductNDC": "72162-1275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207741",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230926",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Ointment, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n-propyl alcohol, n-bulyl alcohol,water, alcohol, chloroform, ether. Structural formula. Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β,16a, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol. Structural formula. Each gram of Nystatin and Triamcinolone Acetonide Ointment, USP provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "72162-1280-6",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72162-1280-6) ",
"NDC11Code": "72162-1280-06",
"ProductNDC": "72162-1280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202214",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141006",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
"Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "72162-1302-6",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1302-6) ",
"NDC11Code": "72162-1302-06",
"ProductNDC": "72162-1302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201807",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231005",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin extended-release capsules have been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis.Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS,Drug Interactions).",
"Description": "Indomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended under INDICATIONS AND USAGE.Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin, USP is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is. C19H16ClNO4 M.W. 357.80 Each extended-release capsule, for oral administration contains 75 mg of indomethacin and the following inactive ingredients: sugar spheres, povidone, mannitol, isopropyl alcohol, talc. The hard gelatin shell consists of gelatin, iron oxide yellow, titanium dioxide, sodium lauryl sulfate. The imprinting ink contains the following: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye and potassium hydroxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "72162-1321-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (72162-1321-2) / 6.6 mL in 1 BOTTLE",
"NDC11Code": "72162-1321-02",
"ProductNDC": "72162-1321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078172",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "80",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240321",
"SamplePackage": "N",
"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.). Ciclopirox topical solution, USP 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. : 1 No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of ciclopirox topical solution, 8% and systemic antifungal agents for onychomycosis, is not recommended., 2 Ciclopirox topical solution, 8% should be used only under medical supervision as described above., 3 The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. The clinical trials with use of ciclopirox topical solution, 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded., 4 The safety and efficacy of using ciclopirox topical solution, 8% daily for greater than 48 weeks have not been established.",
"Description": "Ciclopirox Topical Solution, USP 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, USP 8% (Nail Lacquer) contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, isopropyl alcohol and monobutylester of poly[methyl vinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, USP 8% (Nail Lacquer) is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is."
},
{
"NDCCode": "72162-1330-4",
"PackageDescription": "25 VIAL in 1 BOX, UNIT-DOSE (72162-1330-4) / 1 mL in 1 VIAL (72162-1330-6) ",
"NDC11Code": "72162-1330-04",
"ProductNDC": "72162-1330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital Sodium",
"NonProprietaryName": "Phenobarbital Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20200205",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PHENOBARBITAL SODIUM",
"StrengthNumber": "130",
"StrengthUnit": "mg/mL",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240408",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). . Preanesthetic. Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1 H,3 H,5 H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula:. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72162-2175-6</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72162-2175-6) </PackageDescription>
<NDC11Code>72162-2175-06</NDC11Code>
<ProductNDC>72162-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205129</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>55154-2175-4</NDCCode>
<PackageDescription>100 POUCH in 1 CARTON (55154-2175-4) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (55154-2175-6)</PackageDescription>
<NDC11Code>55154-2175-04</NDC11Code>
<ProductNDC>55154-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62991-2175-6</NDCCode>
<PackageDescription>5 g in 1 JAR (62991-2175-6)</PackageDescription>
<NDC11Code>62991-2175-06</NDC11Code>
<ProductNDC>62991-2175</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Triamcinolone Diacetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111104</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE DIACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72162-2175-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72162-2175-3) </PackageDescription>
<NDC11Code>72162-2175-03</NDC11Code>
<ProductNDC>72162-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205129</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72162-2175-5</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (72162-2175-5) </PackageDescription>
<NDC11Code>72162-2175-05</NDC11Code>
<ProductNDC>72162-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205129</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>43742-2175-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (43742-2175-1) </PackageDescription>
<NDC11Code>43742-2175-01</NDC11Code>
<ProductNDC>43742-2175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Liver Drainage</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Carbolicum Acidum, Carduus Marianus, Chelidonium Majus, Chromium Picolinate, Cichorium Intybus, Flos, Cobalt Gluconate, Copper Gluconate, Gallbladder (suis), Hepar Suis, Magnesium Gluconicum Dihydricum, Natrum Sulphuricum, Nux Vomica, Pancreas Suis, Picrorhiza Kurroa, Ptelea Trifoliate, Raphanus Sativus, Sarcolacticum Acidum, Schisandra Chinensis, Sulphur, Taraxacum Officinale, Vanadium Metallicum, Verbena Officinalis, Flos, Viscum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240529</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; PHENOL; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; CHROMIUM PICOLINATE; CICHORIUM INTYBUS FLOWER; COBALTOUS GLUCONATE; COPPER GLUCONATE; SUS SCROFA GALLBLADDER; PORK LIVER; MAGNESIUM GLUCONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; PICRORHIZA KURROA WHOLE; PTELEA TRIFOLIATA BARK; RADISH; LACTIC ACID, L-; SCHISANDRA CHINENSIS FRUIT; SULFUR; TARAXACUM OFFICINALE; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 8; 2; 1; 6; 8; 6; 6; 8; 8; 6; 6; 8; 8; 10; 6; 3; 6; 2; 6; 2; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the temporary relief of symptoms including. liver discomfort poor digestion low energy. alternating occasional diarrhea and constipation. These statements are based upon homeopathic practices. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-2175-0</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-2175-0) </PackageDescription>
<NDC11Code>50090-2175-00</NDC11Code>
<ProductNDC>50090-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .</IndicationAndUsage>
<Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-2175-1</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (50090-2175-1) </PackageDescription>
<NDC11Code>50090-2175-01</NDC11Code>
<ProductNDC>50090-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .</IndicationAndUsage>
<Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-2175-2</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50090-2175-2) </PackageDescription>
<NDC11Code>50090-2175-02</NDC11Code>
<ProductNDC>50090-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .</IndicationAndUsage>
<Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-2175-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-2175-3) </PackageDescription>
<NDC11Code>50090-2175-03</NDC11Code>
<ProductNDC>50090-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .</IndicationAndUsage>
<Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-2175-4</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-2175-4) </PackageDescription>
<NDC11Code>50090-2175-04</NDC11Code>
<ProductNDC>50090-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3) .</IndicationAndUsage>
<Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film-coated circular shaped tablets. The 12.5 mg tablets are white film-coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 g/mol and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>63083-2175-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2175-2) </PackageDescription>
<NDC11Code>63083-2175-02</NDC11Code>
<ProductNDC>63083-2175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rehydration Drops</ProprietaryName>
<ProprietaryNameSuffix>2175</ProprietaryNameSuffix>
<NonProprietaryName>Rehydration Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; TARAXACUM OFFICINALE; HYPERICUM PERFORATUM WHOLE; ADENOSINE TRIPHOSPHATE; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BEEF KIDNEY; .GAMMA.-AMINOBUTYRIC ACID; GERMANIUM; SEROTONIN</SubstanceName>
<StrengthNumber>1; 1; 3; 4; 4; 6; 6; 6; 6; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63629-2175-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2175-1) </PackageDescription>
<NDC11Code>63629-2175-01</NDC11Code>
<ProductNDC>63629-2175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078992</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate Hydrochloride Extended-release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Dexmethylphenidate Hydrochloride Extended-release Capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threoenantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate Hydrochloride Extended-release Capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate Hydrochloride Extended-release Capsules is intended for oral administration and is available as 15 mg and 30 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is:. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients:sugar spheres, methacrylic acid copolymers, triethyl citrate, talc, colloidal silicon dioxide, Hypromellose, polydextrose, triacetin, macrogol/PEG, FD&C Yellow #6/Sunset Yellow FCF AL, FD&C Blue #2/ indigo carmine AL, titanium dioxide and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>72162-1051-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72162-1051-6) </PackageDescription>
<NDC11Code>72162-1051-06</NDC11Code>
<ProductNDC>72162-1051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaprozin</ProprietaryName>
<NonProprietaryName>Oxaprozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010131</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075845</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXAPROZIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaprozin tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For relief of the signs and symptoms of juvenile rheumatoid arthritis.</IndicationAndUsage>
<Description>Oxaprozin tablets, USP are a nonsteroidal anti-inflammatory drug, available as tablets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293. Its molecular formula is C18H15NO3, and it has the following chemical structure. Oxaprozin, USP is a white to off-white powder with a slight odor and a melting point of 162°C to 163°C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4). The pKa in water is 4.3. Oxaprozin tablets, USP contain 600 mg of oxaprozin, USP. In addition, each tablet of oxaprozin, USP contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, hypromellose, methylcellulose, magnesium stearate, polacrilin potassium, starch, polyethylene glycol, titanium dioxide, and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>72162-1059-6</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-6) </PackageDescription>
<NDC11Code>72162-1059-06</NDC11Code>
<ProductNDC>72162-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078056</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72162-1080-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72162-1080-6) </PackageDescription>
<NDC11Code>72162-1080-06</NDC11Code>
<ProductNDC>72162-1080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077241</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72162-1081-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72162-1081-6) </PackageDescription>
<NDC11Code>72162-1081-06</NDC11Code>
<ProductNDC>72162-1081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077471</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1082-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72162-1082-6) </PackageDescription>
<NDC11Code>72162-1082-06</NDC11Code>
<ProductNDC>72162-1082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077471</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1084-6</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72162-1084-6) </PackageDescription>
<NDC11Code>72162-1084-06</NDC11Code>
<ProductNDC>72162-1084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201407</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>37.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
<Description>Each triamterene and hydrochlorothiazide capsule for oral use contains triamterene 37.5 mg and hydrochlorothiazide 25 mg. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent. Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. Molecular Formula: C7H8CIN3O4S2 M.W. 297.74. At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene is 2,4,7-triamino-6-phenylpteridine and its structural formula is. Molecular Formula: C12H11N7 M.W. 253.26. Inactive ingredients consist of lactose monohydrate, pregelatinized starch, sodium starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and magnesium stearate. The capsule shell consists of titanium dioxide and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules.</Description>
</NDC>
<NDC>
<NDCCode>72162-1108-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72162-1108-6) </PackageDescription>
<NDC11Code>72162-1108-06</NDC11Code>
<ProductNDC>72162-1108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
<NonProprietaryName>Trospium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091573</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium Chloride Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium chloride is a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g per 2 mL. Each Trospium Chloride Tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, povidone, hypromellose, talc, stearic acid, titanium dioxide, colloidal silicon dioxide, magnesium stearate and polyethylene glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>72162-1124-6</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PLASTIC (72162-1124-6) </PackageDescription>
<NDC11Code>72162-1124-06</NDC11Code>
<ProductNDC>72162-1124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystop</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064118</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
<NDC>
<NDCCode>72162-1270-6</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72162-1270-6) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72162-1270-06</NDC11Code>
<ProductNDC>72162-1270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide Topical Solution Usp, 0.05%</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209699</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide topical solution, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide topical solution, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a clear transparent solution of ethyl alcohol (35%),citric acid monohydrate,diisopropyl adipate, propylene glycol and purified water.</Description>
</NDC>
<NDC>
<NDCCode>72162-1271-6</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72162-1271-6) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72162-1271-06</NDC11Code>
<ProductNDC>72162-1271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide Topical Solution Usp, 0.01%</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide Topical Solution Usp, 0.01%</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209913</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Topical Solution, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1, 4-diene-3, 20-dione, 6, 9-difluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis (oxy)]-, (6α, 11β, 16α)-. It has the following chemical structure. Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of anhydrous citric acid and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>72162-1272-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1272-6) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1272-06</NDC11Code>
<ProductNDC>72162-1272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide Ointment, 0.05%</ProprietaryName>
<NonProprietaryName>Desonide Ointment, 0.05%</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210998</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is white to off-white powder. The solubility of desonide in distilled water saturated with the ether is 184 mg/L.Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>72162-1273-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1273-6) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1273-06</NDC11Code>
<ProductNDC>72162-1273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate Ointment Usp, 0.05%</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211295</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>72162-1275-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1275-6) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1275-06</NDC11Code>
<ProductNDC>72162-1275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207741</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Ointment, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n-propyl alcohol, n-bulyl alcohol,water, alcohol, chloroform, ether. Structural formula. Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β,16a, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol. Structural formula. Each gram of Nystatin and Triamcinolone Acetonide Ointment, USP provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>72162-1280-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72162-1280-6) </PackageDescription>
<NDC11Code>72162-1280-06</NDC11Code>
<ProductNDC>72162-1280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202214</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72162-1302-6</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1302-6) </PackageDescription>
<NDC11Code>72162-1302-06</NDC11Code>
<ProductNDC>72162-1302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201807</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin extended-release capsules have been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis.Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS,Drug Interactions).</IndicationAndUsage>
<Description>Indomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended under INDICATIONS AND USAGE.Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin, USP is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is. C19H16ClNO4 M.W. 357.80 Each extended-release capsule, for oral administration contains 75 mg of indomethacin and the following inactive ingredients: sugar spheres, povidone, mannitol, isopropyl alcohol, talc. The hard gelatin shell consists of gelatin, iron oxide yellow, titanium dioxide, sodium lauryl sulfate. The imprinting ink contains the following: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye and potassium hydroxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>72162-1321-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72162-1321-2) / 6.6 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72162-1321-02</NDC11Code>
<ProductNDC>72162-1321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078172</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.). Ciclopirox topical solution, USP 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. : 1 No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of ciclopirox topical solution, 8% and systemic antifungal agents for onychomycosis, is not recommended., 2 Ciclopirox topical solution, 8% should be used only under medical supervision as described above., 3 The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. The clinical trials with use of ciclopirox topical solution, 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded., 4 The safety and efficacy of using ciclopirox topical solution, 8% daily for greater than 48 weeks have not been established.</IndicationAndUsage>
<Description>Ciclopirox Topical Solution, USP 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, USP 8% (Nail Lacquer) contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, isopropyl alcohol and monobutylester of poly[methyl vinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, USP 8% (Nail Lacquer) is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>72162-1330-4</NDCCode>
<PackageDescription>25 VIAL in 1 BOX, UNIT-DOSE (72162-1330-4) / 1 mL in 1 VIAL (72162-1330-6) </PackageDescription>
<NDC11Code>72162-1330-04</NDC11Code>
<ProductNDC>72162-1330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital Sodium</ProprietaryName>
<NonProprietaryName>Phenobarbital Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200205</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PHENOBARBITAL SODIUM</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). . Preanesthetic. Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1 H,3 H,5 H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula:. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform.</Description>
</NDC>
</NDCList>