{
"NDC": [
{
"NDCCode": "55494-100-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) ",
"NDC11Code": "55494-0100-10",
"ProductNDC": "55494-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclegis",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021876",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
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"IndicationAndUsage": "DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.",
"Description": "DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) ",
"NDC11Code": "55494-0120-10",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180219",
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"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-100-99",
"PackageDescription": "12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) ",
"NDC11Code": "55494-0100-99",
"ProductNDC": "55494-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclegis",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021876",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20140328",
"SamplePackage": "Y",
"IndicationAndUsage": "DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.",
"Description": "DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) ",
"NDC11Code": "55494-0120-60",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-94",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55494-0120-94",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250226",
"SamplePackage": "Y",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-99",
"PackageDescription": "6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) ",
"NDC11Code": "55494-0120-99",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180219",
"SamplePackage": "Y",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"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",
"IndicationAndUsage": "DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.",
"Description": "The active ingredient in DIPENTUM (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to mesalamine (5-aminosalicylic acid,5-ASA), an aminosalicylate. Its empirical formula is C14H8N2Na2O6 with a molecular weight of 346.20. The structural formula is. Olsalazine sodium is a yellow crystalline powder, which is not melted below 300°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions. DIPENTUM is supplied in capsules for oral administration. Each DIPENTUM hard gelatin capsule contains 250 mg olsalazine sodium (equivalent to 233.4 mg of olsalazine). The inert ingredient in each capsule is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide."
},
{
"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",
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"LabelerName": "Sanofi-Aventis U.S. LLC",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Pharm_Classes": "Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]",
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},
{
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "CARDURA is an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "CARDURA® (doxazosin) is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C23H25N5O5 ∙ CH4O3S and the molecular weight is 547.6. It has the following structure. CARDURA (doxazosin) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. CARDURA is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg orange tablet contains FD & C yellow 6; the 8 mg green tablet contains FD & C blue 2 and D & C yellow 10."
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{
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}
]
}
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<Description>DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
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<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>Y</SamplePackage>
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<Description>DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
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<LabelerName>Duchesnay USA, Inc.</LabelerName>
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<Status>Active</Status>
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<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
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<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250226</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-120-99</NDCCode>
<PackageDescription>6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) </PackageDescription>
<NDC11Code>55494-0120-99</NDC11Code>
<ProductNDC>55494-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</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>
<IndicationAndUsage>DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.</IndicationAndUsage>
<Description>The active ingredient in DIPENTUM (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to mesalamine (5-aminosalicylic acid,5-ASA), an aminosalicylate. Its empirical formula is C14H8N2Na2O6 with a molecular weight of 346.20. The structural formula is. Olsalazine sodium is a yellow crystalline powder, which is not melted below 300°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions. DIPENTUM is supplied in capsules for oral administration. Each DIPENTUM hard gelatin capsule contains 250 mg olsalazine sodium (equivalent to 233.4 mg of olsalazine). The inert ingredient in each capsule is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide.</Description>
</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>
<NDC>
<NDCCode>0039-0223-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0223-10) </PackageDescription>
<NDC11Code>00039-0223-10</NDC11Code>
<ProductNDC>0039-0223</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>4</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>
<NDC>
<NDCCode>0049-2410-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0049-2410-10) </PackageDescription>
<NDC11Code>00049-2410-10</NDC11Code>
<ProductNDC>0049-2410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardura</ProprietaryName>
<NonProprietaryName>Doxazosin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211019</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019668</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211019</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDURA is an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>CARDURA® (doxazosin) is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C23H25N5O5 ∙ CH4O3S and the molecular weight is 547.6. It has the following structure. CARDURA (doxazosin) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. CARDURA is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg orange tablet contains FD & C yellow 6; the 8 mg green tablet contains FD & C blue 2 and D & C yellow 10.</Description>
</NDC>
<NDC>
<NDCCode>0049-2512-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0049-2512-10) </PackageDescription>
<NDC11Code>00049-2512-10</NDC11Code>
<ProductNDC>0049-2512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardura</ProprietaryName>
<NonProprietaryName>Doxazosin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019668</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDURA is an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>CARDURA® (doxazosin) is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C23H25N5O5 ∙ CH4O3S and the molecular weight is 547.6. It has the following structure. CARDURA (doxazosin) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. CARDURA is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg orange tablet contains FD & C yellow 6; the 8 mg green tablet contains FD & C blue 2 and D & C yellow 10.</Description>
</NDC>
</NDCList>