{
"NDC": [
{
"NDCCode": "23359-100-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (23359-100-10) ",
"NDC11Code": "23359-0100-10",
"ProductNDC": "23359-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Centratex",
"NonProprietaryName": "Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090614",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE",
"StrengthNumber": "10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [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], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090614",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery."
},
{
"NDCCode": "23359-032-10",
"PackageDescription": "10 mL in 1 BOTTLE (23359-032-10) ",
"NDC11Code": "23359-0032-10",
"ProductNDC": "23359-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof",
"NonProprietaryName": "Chlophedianol Hcl And Pyrilamine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "12.5; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170918",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes."
},
{
"NDCCode": "23359-100-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (23359-100-30) ",
"NDC11Code": "23359-0100-30",
"ProductNDC": "23359-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Centratex",
"NonProprietaryName": "Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090614",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE",
"StrengthNumber": "10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [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], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090614",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery."
},
{
"NDCCode": "23359-105-01",
"PackageDescription": "1 CAPSULE, GELATIN COATED in 1 PACKET (23359-105-01) ",
"NDC11Code": "23359-0105-01",
"ProductNDC": "23359-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "C-nate Dha",
"NonProprietaryName": "Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE",
"StrengthNumber": "30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "23359-105-05",
"PackageDescription": "5 CAPSULE, GELATIN COATED in 1 CARTON (23359-105-05) ",
"NDC11Code": "23359-0105-05",
"ProductNDC": "23359-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "C-nate Dha",
"NonProprietaryName": "Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE",
"StrengthNumber": "30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "23359-105-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (23359-105-30) ",
"NDC11Code": "23359-0105-30",
"ProductNDC": "23359-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "C-nate Dha",
"NonProprietaryName": "Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE",
"StrengthNumber": "30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "23359-700-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (23359-700-30)",
"NDC11Code": "23359-0700-30",
"ProductNDC": "23359-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Puralor",
"NonProprietaryName": "1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, Egg Phospholipids , Folic Acid, Leucovorin, Levomefolic Acid, Anhydrous Citric Acid, Sodium Citrate, Magnesium Glycinate, Acetylcysteine Amide, Cholecalciferol, Thiamine, Riboflavin, Pantethine, Niacin, Cobamamide, Ascorbic Acid, Magnesium L-threonate, Papain And Intrinsic Factor",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE; 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE; EGG PHOSPHOLIPIDS; FOLIC ACID; LEUCOVORIN; LEVOMEFOLIC ACID; ANHYDROUS CITRIC ACID; SODIUM CITRATE; MAGNESIUM GLYCINATE; ACETYLCYSTEINE AMIDE; CHOLECALCIFEROL; THIAMINE; RIBOFLAVIN; PANTETHINE; NIACIN; COBAMAMIDE; ASCORBIC ACID; MAGNESIUM L-THREONATE; PAPAIN; INTRINSIC FACTOR",
"StrengthNumber": "5; 2.5; 42.5; .2; 3; .4; 1.6; .8; 1; 5; 100; .5; .5; 2.5; .5; 2; 25; 2.5; 20; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-13"
},
{
"NDCCode": "23359-016-16",
"PackageDescription": "473 mL in 1 BOTTLE (23359-016-16)",
"NDC11Code": "23359-0016-16",
"ProductNDC": "23359-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lexuss 210",
"NonProprietaryName": "Codeine Phosphate And Chlorpheniramine Maleate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090415",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs",
"SubstanceName": "CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "10; 2",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "23359-023-16",
"PackageDescription": "473 mL in 1 BOTTLE (23359-023-16)",
"NDC11Code": "23359-0023-16",
"ProductNDC": "23359-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rydex",
"NonProprietaryName": "Brompheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Centurion Labs",
"SubstanceName": "BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1.33; 6.33; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-1040-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00008-1040-10",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1041-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-1041-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00008-1041-10",
"ProductNDC": "0008-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20010701",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0009-5093-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00009-5093-10",
"ProductNDC": "0009-5093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ellence",
"NonProprietaryName": "Epirubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19990915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050778",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "EPIRUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250324",
"SamplePackage": "N",
"IndicationAndUsage": "ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1)].",
"Description": "ELLENCE (epirubicin hydrochloride injection) is an anthracycline topoisomerase inhibitor for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution. Each milliliter of solution contains 2 mg of epirubicin hydrochloride. Inactive ingredients include 9 mg sodium chloride, USP, and water for injection, USP. The pH of the solution has been adjusted to 3.0 with hydrochloric acid and/or sodium hydroxide, NF. Epirubicin hydrochloride is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin. The chemical name is (8S-cis)-10-[(3-amino-2,3,6-trideoxy-α-L- arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione hydrochloride. The active ingredient is a red-orange hygroscopic powder, with the empirical formula C27 H29 NO11 HCl and a molecular weight of 579.95. The structural formula is as follows."
},
{
"NDCCode": "0009-5137-04",
"PackageDescription": "10 BAG in 1 BOX (0009-5137-04) / 100 mL in 1 BAG (0009-5137-01) ",
"NDC11Code": "00009-5137-04",
"ProductNDC": "0009-5137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyvox",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000418",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021131",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "200",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000418",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N"
},
{
"NDCCode": "0013-0101-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00013-0101-10",
"ProductNDC": "0013-0101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azulfidine",
"NonProprietaryName": "Sulfasalazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19500620",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA007073",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SULFASALAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200227",
"SamplePackage": "N",
"IndicationAndUsage": "AZULFIDINE Tablets are indicated: 1 in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and, 2 for the prolongation of the remission period between acute attacks of ulcerative colitis.",
"Description": "AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. Molecular Formula: C18H14N4O5S. Inactive ingredients: magnesium stearate, povidone, silica (colloidal anhydrous), starch (pregelatinized)."
},
{
"NDCCode": "0019-0953-10",
"PackageDescription": "12 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00019-0953-10",
"ProductNDC": "0019-0953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Conray",
"NonProprietaryName": "Iothalamate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20031014",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA013295",
"LabelerName": "Liebel-Flarsheim Company LLC",
"SubstanceName": "IOTHALAMATE MEGLUMINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20031014",
"SamplePackage": "N",
"IndicationAndUsage": "Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT (see CLINICAL PHARMACOLOGY). Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.",
"Description": "Conray is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray contains 60% w/v iothalamate meglumine, which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6 triiodo-N-methylisophthalamate (salt), and has the following structural formula:. Each milliliter contains 600 mg of iothalamate meglumine, 0.09 mg edetate calcium disodium as a stabilizer and 0.125 mg of monobasic sodium phosphate as a buffer. The solution provides 28.2% (282 mg/mL) organically bound iodine. Conray has an osmolarity of approximately 1000 mOsmol per liter, an osmolality of approximately 1400 mOsmol per kilogram and is, therefore, hypertonic under conditions of use. The viscosity (cps) is approximately 6 at 25°C and 4 at 37°C. The pH is 6.5 to 7.7. Conray is a clear solution containing no undissolved solids. Crystallization does not occur at normal room temperatures. It is supplied in containers from which the air has been displaced by nitrogen."
},
{
"NDCCode": "0023-0042-10",
"PackageDescription": "1 TUBE in 1 CARTON (0023-0042-10) / 100 g in 1 TUBE",
"NDC11Code": "00023-0042-10",
"ProductNDC": "0023-0042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tazorac",
"NonProprietaryName": "Tazarotene",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "19970801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020600",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "TAZAROTENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19970801",
"SamplePackage": "N",
"IndicationAndUsage": "TAZORAC® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
"Description": "TAZORAC (tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. TAZORAC Gel contains the following inactive ingredients. benzyl alcohol 1%;ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
},
{
"NDCCode": "0023-0403-10",
"PackageDescription": "100 VIAL, SINGLE-USE in 1 CARTON (0023-0403-10) / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00023-0403-10",
"ProductNDC": "0023-0403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Refresh Plus",
"NonProprietaryName": "Carboxymethylcellulose Sodium",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19961009",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19961009",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation."
},
{
"NDCCode": "0023-8335-10",
"PackageDescription": "1 TUBE in 1 CARTON (0023-8335-10) / 100 g in 1 TUBE",
"NDC11Code": "00023-8335-10",
"ProductNDC": "0023-8335",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tazorac",
"NonProprietaryName": "Tazarotene",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "19970801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020600",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "TAZAROTENE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19970801",
"SamplePackage": "N",
"IndicationAndUsage": "TAZORAC® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
"Description": "TAZORAC (tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. TAZORAC Gel contains the following inactive ingredients. benzyl alcohol 1%;ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
},
{
"NDCCode": "0024-0393-10",
"PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0024-0393-10)",
"NDC11Code": "00024-0393-10",
"ProductNDC": "0024-0393",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drisdol",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "19741111",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA003444",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "0024-1562-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0024-1562-10)",
"NDC11Code": "00024-1562-10",
"ProductNDC": "0024-1562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plaquenil",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19550418",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009768",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC],Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0024-4200-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (0024-4200-10) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "00024-4200-10",
"ProductNDC": "0024-4200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uroxatral",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090605",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021287",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
},
{
"NDCCode": "0029-6579-21",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 TRAY (0029-6579-21) > 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00029-6579-21",
"ProductNDC": "0029-6579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timentin",
"NonProprietaryName": "Ticarcillin Disodium And Clavulanate Potassium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901022",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050590",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM",
"StrengthNumber": "1; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "0037-2250-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10) ",
"NDC11Code": "00037-2250-10",
"ProductNDC": "0037-2250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soma",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011792",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070908",
"SamplePackage": "N",
"IndicationAndUsage": "SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate."
},
{
"NDCCode": "0037-6860-10",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10) ",
"NDC11Code": "00037-6860-10",
"ProductNDC": "0037-6860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipentum",
"NonProprietaryName": "Olsalazine Sodium",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019715",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "OLSALAZINE SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150515",
"SamplePackage": "N"
},
{
"NDCCode": "0039-0051-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (0039-0051-10)",
"NDC11Code": "00039-0051-10",
"ProductNDC": "0039-0051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diabeta",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017532",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-05-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0039-0052-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (0039-0052-10)",
"NDC11Code": "00039-0052-10",
"ProductNDC": "0039-0052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diabeta",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017532",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-05-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0039-0067-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (0039-0067-10)",
"NDC11Code": "00039-0067-10",
"ProductNDC": "0039-0067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lasix",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19660701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016273",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0039-0078-10",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0039-0078-10)",
"NDC11Code": "00039-0078-10",
"ProductNDC": "0039-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trental",
"NonProprietaryName": "Pentoxifylline",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19840830",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018631",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "PENTOXIFYLLINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-06-03"
},
{
"NDCCode": "0039-0221-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (0039-0221-10) ",
"NDC11Code": "00039-0221-10",
"ProductNDC": "0039-0221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amaryl",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090618",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020496",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090618",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "0039-0222-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (0039-0222-10) ",
"NDC11Code": "00039-0222-10",
"ProductNDC": "0039-0222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amaryl",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090618",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020496",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090618",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
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<NDC11Code>23359-0100-10</NDC11Code>
<ProductNDC>23359-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Centratex</ProprietaryName>
<NonProprietaryName>Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE</SubstanceName>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [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], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-032-10</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (23359-032-10) </PackageDescription>
<NDC11Code>23359-0032-10</NDC11Code>
<ProductNDC>23359-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>12.5; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-100-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (23359-100-30) </PackageDescription>
<NDC11Code>23359-0100-30</NDC11Code>
<ProductNDC>23359-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Centratex</ProprietaryName>
<NonProprietaryName>Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE</SubstanceName>
<StrengthNumber>10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [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], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-105-01</NDCCode>
<PackageDescription>1 CAPSULE, GELATIN COATED in 1 PACKET (23359-105-01) </PackageDescription>
<NDC11Code>23359-0105-01</NDC11Code>
<ProductNDC>23359-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>C-nate Dha</ProprietaryName>
<NonProprietaryName>Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-105-05</NDCCode>
<PackageDescription>5 CAPSULE, GELATIN COATED in 1 CARTON (23359-105-05) </PackageDescription>
<NDC11Code>23359-0105-05</NDC11Code>
<ProductNDC>23359-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>C-nate Dha</ProprietaryName>
<NonProprietaryName>Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-105-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (23359-105-30) </PackageDescription>
<NDC11Code>23359-0105-30</NDC11Code>
<ProductNDC>23359-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>C-nate Dha</ProprietaryName>
<NonProprietaryName>Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-700-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (23359-700-30)</PackageDescription>
<NDC11Code>23359-0700-30</NDC11Code>
<ProductNDC>23359-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Puralor</ProprietaryName>
<NonProprietaryName>1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, Egg Phospholipids , Folic Acid, Leucovorin, Levomefolic Acid, Anhydrous Citric Acid, Sodium Citrate, Magnesium Glycinate, Acetylcysteine Amide, Cholecalciferol, Thiamine, Riboflavin, Pantethine, Niacin, Cobamamide, Ascorbic Acid, Magnesium L-threonate, Papain And Intrinsic Factor</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE; 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE; EGG PHOSPHOLIPIDS; FOLIC ACID; LEUCOVORIN; LEVOMEFOLIC ACID; ANHYDROUS CITRIC ACID; SODIUM CITRATE; MAGNESIUM GLYCINATE; ACETYLCYSTEINE AMIDE; CHOLECALCIFEROL; THIAMINE; RIBOFLAVIN; PANTETHINE; NIACIN; COBAMAMIDE; ASCORBIC ACID; MAGNESIUM L-THREONATE; PAPAIN; INTRINSIC FACTOR</SubstanceName>
<StrengthNumber>5; 2.5; 42.5; .2; 3; .4; 1.6; .8; 1; 5; 100; .5; .5; 2.5; .5; 2; 25; 2.5; 20; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>23359-016-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (23359-016-16)</PackageDescription>
<NDC11Code>23359-0016-16</NDC11Code>
<ProductNDC>23359-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lexuss 210</ProprietaryName>
<NonProprietaryName>Codeine Phosphate And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>10; 2</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>23359-023-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (23359-023-16)</PackageDescription>
<NDC11Code>23359-0023-16</NDC11Code>
<ProductNDC>23359-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rydex</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Centurion Labs</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.33; 6.33; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-1040-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-1040-10</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100301</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-1041-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-1041-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-1041-10</NDC11Code>
<ProductNDC>0008-1041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010701</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20010701</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0009-5093-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00009-5093-10</NDC11Code>
<ProductNDC>0009-5093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ellence</ProprietaryName>
<NonProprietaryName>Epirubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19990915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050778</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>EPIRUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>ELLENCE (epirubicin hydrochloride injection) is an anthracycline topoisomerase inhibitor for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution. Each milliliter of solution contains 2 mg of epirubicin hydrochloride. Inactive ingredients include 9 mg sodium chloride, USP, and water for injection, USP. The pH of the solution has been adjusted to 3.0 with hydrochloric acid and/or sodium hydroxide, NF. Epirubicin hydrochloride is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin. The chemical name is (8S-cis)-10-[(3-amino-2,3,6-trideoxy-α-L- arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione hydrochloride. The active ingredient is a red-orange hygroscopic powder, with the empirical formula C27 H29 NO11 HCl and a molecular weight of 579.95. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>0009-5137-04</NDCCode>
<PackageDescription>10 BAG in 1 BOX (0009-5137-04) / 100 mL in 1 BAG (0009-5137-01) </PackageDescription>
<NDC11Code>00009-5137-04</NDC11Code>
<ProductNDC>0009-5137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyvox</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000418</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021131</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000418</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0013-0101-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00013-0101-10</NDC11Code>
<ProductNDC>0013-0101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azulfidine</ProprietaryName>
<NonProprietaryName>Sulfasalazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19500620</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA007073</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SULFASALAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AZULFIDINE Tablets are indicated: 1 in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and, 2 for the prolongation of the remission period between acute attacks of ulcerative colitis.</IndicationAndUsage>
<Description>AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. Molecular Formula: C18H14N4O5S. Inactive ingredients: magnesium stearate, povidone, silica (colloidal anhydrous), starch (pregelatinized).</Description>
</NDC>
<NDC>
<NDCCode>0019-0953-10</NDCCode>
<PackageDescription>12 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00019-0953-10</NDC11Code>
<ProductNDC>0019-0953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Conray</ProprietaryName>
<NonProprietaryName>Iothalamate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20031014</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA013295</ApplicationNumber>
<LabelerName>Liebel-Flarsheim Company LLC</LabelerName>
<SubstanceName>IOTHALAMATE MEGLUMINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT (see CLINICAL PHARMACOLOGY). Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.</IndicationAndUsage>
<Description>Conray is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray contains 60% w/v iothalamate meglumine, which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6 triiodo-N-methylisophthalamate (salt), and has the following structural formula:. Each milliliter contains 600 mg of iothalamate meglumine, 0.09 mg edetate calcium disodium as a stabilizer and 0.125 mg of monobasic sodium phosphate as a buffer. The solution provides 28.2% (282 mg/mL) organically bound iodine. Conray has an osmolarity of approximately 1000 mOsmol per liter, an osmolality of approximately 1400 mOsmol per kilogram and is, therefore, hypertonic under conditions of use. The viscosity (cps) is approximately 6 at 25°C and 4 at 37°C. The pH is 6.5 to 7.7. Conray is a clear solution containing no undissolved solids. Crystallization does not occur at normal room temperatures. It is supplied in containers from which the air has been displaced by nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>0023-0042-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0023-0042-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>00023-0042-10</NDC11Code>
<ProductNDC>0023-0042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tazorac</ProprietaryName>
<NonProprietaryName>Tazarotene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>19970801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020600</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>TAZAROTENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAZORAC® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
<Description>TAZORAC (tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. TAZORAC Gel contains the following inactive ingredients. benzyl alcohol 1%;ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>0023-0403-10</NDCCode>
<PackageDescription>100 VIAL, SINGLE-USE in 1 CARTON (0023-0403-10) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00023-0403-10</NDC11Code>
<ProductNDC>0023-0403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Refresh Plus</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19961009</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0023-8335-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0023-8335-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>00023-8335-10</NDC11Code>
<ProductNDC>0023-8335</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tazorac</ProprietaryName>
<NonProprietaryName>Tazarotene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>19970801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020600</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>TAZAROTENE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAZORAC® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
<Description>TAZORAC (tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. TAZORAC Gel contains the following inactive ingredients. benzyl alcohol 1%;ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>0024-0393-10</NDCCode>
<PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0024-0393-10)</PackageDescription>
<NDC11Code>00024-0393-10</NDC11Code>
<ProductNDC>0024-0393</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drisdol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19741111</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA003444</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-1562-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0024-1562-10)</PackageDescription>
<NDC11Code>00024-1562-10</NDC11Code>
<ProductNDC>0024-1562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plaquenil</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550418</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009768</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antirheumatic Agent [EPC],Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0024-4200-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0024-4200-10) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>00024-4200-10</NDC11Code>
<ProductNDC>0024-4200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uroxatral</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090605</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021287</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0029-6579-21</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 TRAY (0029-6579-21) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00029-6579-21</NDC11Code>
<ProductNDC>0029-6579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timentin</ProprietaryName>
<NonProprietaryName>Ticarcillin Disodium And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<EndMarketingDate>20150731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050590</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM</SubstanceName>
<StrengthNumber>1; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>0037-2250-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10) </PackageDescription>
<NDC11Code>00037-2250-10</NDC11Code>
<ProductNDC>0037-2250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soma</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011792</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>0037-6860-10</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10) </PackageDescription>
<NDC11Code>00037-6860-10</NDC11Code>
<ProductNDC>0037-6860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipentum</ProprietaryName>
<NonProprietaryName>Olsalazine Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019715</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>OLSALAZINE SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0039-0051-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0051-10)</PackageDescription>
<NDC11Code>00039-0051-10</NDC11Code>
<ProductNDC>0039-0051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diabeta</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017532</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0039-0052-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0052-10)</PackageDescription>
<NDC11Code>00039-0052-10</NDC11Code>
<ProductNDC>0039-0052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diabeta</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017532</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0039-0067-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0067-10)</PackageDescription>
<NDC11Code>00039-0067-10</NDC11Code>
<ProductNDC>0039-0067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lasix</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19660701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016273</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0039-0078-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0039-0078-10)</PackageDescription>
<NDC11Code>00039-0078-10</NDC11Code>
<ProductNDC>0039-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trental</ProprietaryName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840830</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018631</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-06-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0039-0221-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0221-10) </PackageDescription>
<NDC11Code>00039-0221-10</NDC11Code>
<ProductNDC>0039-0221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amaryl</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090618</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020496</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090618</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0039-0222-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0222-10) </PackageDescription>
<NDC11Code>00039-0222-10</NDC11Code>
<ProductNDC>0039-0222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amaryl</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090618</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020496</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090618</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>