{
"NDC": [
{
"NDCCode": "16110-391-55",
"PackageDescription": "5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET",
"NDC11Code": "16110-0391-55",
"ProductNDC": "16110-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klisyri",
"NonProprietaryName": "Tirbanibulin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213189",
"LabelerName": "Almirall, LLC",
"SubstanceName": "TIRBANIBULIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240607",
"SamplePackage": "N",
"IndicationAndUsage": "KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.",
"Description": "KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. The molecular weight is 431.4 and the molecular formula is C26H29N3O3. Tirbanibulin’s structural formula is. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol."
},
{
"NDCCode": "16110-391-05",
"PackageDescription": "5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET",
"NDC11Code": "16110-0391-05",
"ProductNDC": "16110-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klisyri",
"NonProprietaryName": "Tirbanibulin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213189",
"LabelerName": "Almirall, LLC",
"SubstanceName": "TIRBANIBULIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.",
"Description": "KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. The molecular weight is 431.4 and the molecular formula is C26H29N3O3. Tirbanibulin’s structural formula is. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol."
},
{
"NDCCode": "0093-1125-89",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0093-1125-89) ",
"NDC11Code": "00093-1125-89",
"ProductNDC": "0093-1125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208432",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181121",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. C26H33NO2 M.W. 391.55. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available as 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "0378-6920-78",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78) ",
"NDC11Code": "00378-6920-78",
"ProductNDC": "0378-6920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208446",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181121",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. , 2 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. ."
},
{
"NDCCode": "0378-6921-91",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91) ",
"NDC11Code": "00378-6921-91",
"ProductNDC": "0378-6921",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208446",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. , 2 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. ."
},
{
"NDCCode": "0591-4365-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0591-4365-60) ",
"NDC11Code": "00591-4365-60",
"ProductNDC": "0591-4365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210726",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230713",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "0904-6948-04",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0904-6948-04) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-6948-04",
"ProductNDC": "0904-6948",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208453",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181123",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-‑17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate."
},
{
"NDCCode": "16714-963-01",
"PackageDescription": "120 TABLET in 1 BOTTLE (16714-963-01) ",
"NDC11Code": "16714-0963-01",
"ProductNDC": "16714-963",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208416",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200519",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with. Metastatic castration-resistant prostate cancer (CRPC). Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42291-024-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (42291-024-12) ",
"NDC11Code": "42291-0024-12",
"ProductNDC": "42291-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "AvKARE",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending."
},
{
"NDCCode": "42291-073-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42291-073-60) ",
"NDC11Code": "42291-0073-60",
"ProductNDC": "42291-073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "AvKARE",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210429",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
},
{
"NDCCode": "43598-358-04",
"PackageDescription": "120 TABLET in 1 BOTTLE (43598-358-04) ",
"NDC11Code": "43598-0358-04",
"ProductNDC": "43598-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208416",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200519",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "43598-358-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (43598-358-31) / 10 TABLET in 1 BLISTER PACK (43598-358-79) ",
"NDC11Code": "43598-0358-31",
"ProductNDC": "43598-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208416",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211220",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "43598-468-38",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79) ",
"NDC11Code": "43598-0468-38",
"ProductNDC": "43598-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208416",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230911",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "43598-468-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (43598-468-60) ",
"NDC11Code": "43598-0468-60",
"ProductNDC": "43598-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208416",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230911",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "47335-401-81",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81) ",
"NDC11Code": "47335-0401-81",
"ProductNDC": "47335-401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yonsa",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210308",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180522",
"SamplePackage": "N",
"IndicationAndUsage": "YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.",
"Description": "Abiraterone acetate, the active ingredient of YONSA tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each YONSA Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene."
},
{
"NDCCode": "50268-032-12",
"PackageDescription": "20 BLISTER PACK in 1 BOX (50268-032-12) / 1 TABLET in 1 BLISTER PACK (50268-032-11) ",
"NDC11Code": "50268-0032-12",
"ProductNDC": "50268-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208416",
"LabelerName": "AvPAK",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "51407-503-12",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (51407-503-12) ",
"NDC11Code": "51407-0503-12",
"ProductNDC": "51407-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210308",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250904",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.",
"Description": "Abiraterone acetate, the active ingredient of Abiraterone Acetate tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone Acetate Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene."
},
{
"NDCCode": "51407-989-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-989-60) ",
"NDC11Code": "51407-0989-60",
"ProductNDC": "51407-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208446",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260617",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin., 2 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "57894-150-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (57894-150-12) ",
"NDC11Code": "57894-0150-12",
"ProductNDC": "57894-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zytiga",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202379",
"LabelerName": "Janssen Biotech, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110428",
"SamplePackage": "N",
"IndicationAndUsage": "ZYTIGA is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of ZYTIGA ® is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. ZYTIGA tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ®II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "57894-195-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06) ",
"NDC11Code": "57894-0195-06",
"ProductNDC": "57894-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zytiga",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202379",
"LabelerName": "Janssen Biotech, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170417",
"SamplePackage": "N",
"IndicationAndUsage": "ZYTIGA is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of ZYTIGA ® is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. ZYTIGA tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ®II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "57894-195-15",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15) ",
"NDC11Code": "57894-0195-15",
"ProductNDC": "57894-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zytiga",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202379",
"LabelerName": "Janssen Biotech, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170417",
"SamplePackage": "Y",
"IndicationAndUsage": "ZYTIGA is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of ZYTIGA ® is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. ZYTIGA tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ®II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "58411-391-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-391-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0391-60",
"ProductNDC": "58411-391",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer",
"ProprietaryNameSuffix": "Oil Free Broad Spectrum Spf 20 Sunscreen 6w1 Mocha",
"NonProprietaryName": "Octinoxate And Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "55; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ABIRATERONE ACETATE",
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"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
},
{
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"PackageDescription": "60 TABLET in 1 BOTTLE (60219-1754-6) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
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"RouteName": "ORAL",
"StartMarketingDate": "20230428",
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"ApplicationNumber": "ANDA208327",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ABIRATERONE ACETATE",
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"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
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{
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"PackageDescription": "120 TABLET in 1 BOTTLE (60505-4327-1) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208453",
"LabelerName": "Apotex Corp.",
"SubstanceName": "ABIRATERONE ACETATE",
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"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate."
},
{
"NDCCode": "60505-4764-6",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"StartMarketingDate": "20210716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212462",
"LabelerName": "Apotex Corp.",
"SubstanceName": "ABIRATERONE ACETATE",
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"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
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"IndicationAndUsage": "Abiraterone acetate is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H 33NO2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg film-coated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose PH101, and sodium lauryl sulfate. The coating, Opadry® 85F100098-CN Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
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"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-455-21) / 1 TABLET in 1 BLISTER PACK (60687-455-11) ",
"NDC11Code": "60687-0455-21",
"ProductNDC": "60687-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
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"RouteName": "ORAL",
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"LabelerName": "American Health Packaging",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
},
{
"NDCCode": "64679-021-01",
"PackageDescription": "120 TABLET in 1 BOTTLE (64679-021-01) ",
"NDC11Code": "64679-0021-01",
"ProductNDC": "64679-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
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"RouteName": "ORAL",
"StartMarketingDate": "20190227",
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"ApplicationNumber": "ANDA208380",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ABIRATERONE ACETATE",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC)., 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β) -17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water, soluble in methanol and chloroform. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "64980-418-12",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
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"StartMarketingDate": "20190225",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Rising Pharma Holdings, Inc.",
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"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
}
]
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<StartMarketingDatePackage>20181121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. C26H33NO2 M.W. 391.55. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available as 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
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<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78) </PackageDescription>
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<ProductNDC>0378-6920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208446</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. , 2 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. .</Description>
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<ApplicationNumber>ANDA208446</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. , 2 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. .</Description>
</NDC>
<NDC>
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<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0591-4365-60) </PackageDescription>
<NDC11Code>00591-4365-60</NDC11Code>
<ProductNDC>0591-4365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210726</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (0904-6948-04) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6948-04</NDC11Code>
<ProductNDC>0904-6948</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208453</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-‑17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>16714-963-01</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (16714-963-01) </PackageDescription>
<NDC11Code>16714-0963-01</NDC11Code>
<ProductNDC>16714-963</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208416</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with. Metastatic castration-resistant prostate cancer (CRPC). Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42291-024-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (42291-024-12) </PackageDescription>
<NDC11Code>42291-0024-12</NDC11Code>
<ProductNDC>42291-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>42291-073-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42291-073-60) </PackageDescription>
<NDC11Code>42291-0073-60</NDC11Code>
<ProductNDC>42291-073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>43598-358-04</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (43598-358-04) </PackageDescription>
<NDC11Code>43598-0358-04</NDC11Code>
<ProductNDC>43598-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208416</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-358-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (43598-358-31) / 10 TABLET in 1 BLISTER PACK (43598-358-79) </PackageDescription>
<NDC11Code>43598-0358-31</NDC11Code>
<ProductNDC>43598-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208416</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
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<PackageDescription>6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79) </PackageDescription>
<NDC11Code>43598-0468-38</NDC11Code>
<ProductNDC>43598-468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
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<StartMarketingDate>20230911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208416</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-12</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
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<NDCCode>43598-468-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (43598-468-60) </PackageDescription>
<NDC11Code>43598-0468-60</NDC11Code>
<ProductNDC>43598-468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208416</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-12</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC) , 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-401-81</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81) </PackageDescription>
<NDC11Code>47335-0401-81</NDC11Code>
<ProductNDC>47335-401</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yonsa</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210308</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of YONSA tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each YONSA Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene.</Description>
</NDC>
<NDC>
<NDCCode>50268-032-12</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX (50268-032-12) / 1 TABLET in 1 BLISTER PACK (50268-032-11) </PackageDescription>
<NDC11Code>50268-0032-12</NDC11Code>
<ProductNDC>50268-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208416</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 1 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51407-503-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (51407-503-12) </PackageDescription>
<NDC11Code>51407-0503-12</NDC11Code>
<ProductNDC>51407-503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210308</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of Abiraterone Acetate tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone Acetate Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene.</Description>
</NDC>
<NDC>
<NDCCode>51407-989-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-989-60) </PackageDescription>
<NDC11Code>51407-0989-60</NDC11Code>
<ProductNDC>51407-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208446</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin., 2 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>57894-150-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (57894-150-12) </PackageDescription>
<NDC11Code>57894-0150-12</NDC11Code>
<ProductNDC>57894-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zytiga</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202379</ApplicationNumber>
<LabelerName>Janssen Biotech, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYTIGA is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of ZYTIGA ® is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. ZYTIGA tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ®II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>57894-195-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06) </PackageDescription>
<NDC11Code>57894-0195-06</NDC11Code>
<ProductNDC>57894-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zytiga</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202379</ApplicationNumber>
<LabelerName>Janssen Biotech, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYTIGA is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of ZYTIGA ® is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. ZYTIGA tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ®II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>57894-195-15</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15) </PackageDescription>
<NDC11Code>57894-0195-15</NDC11Code>
<ProductNDC>57894-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zytiga</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202379</ApplicationNumber>
<LabelerName>Janssen Biotech, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170417</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ZYTIGA is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of ZYTIGA ® is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. ZYTIGA tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ®II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>58411-391-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-391-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0391-60</NDC11Code>
<ProductNDC>58411-391</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Oil Free Broad Spectrum Spf 20 Sunscreen 6w1 Mocha</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>55; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60219-1165-7</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (60219-1165-7) </PackageDescription>
<NDC11Code>60219-1165-07</NDC11Code>
<ProductNDC>60219-1165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>60219-1754-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (60219-1754-6) </PackageDescription>
<NDC11Code>60219-1754-06</NDC11Code>
<ProductNDC>60219-1754</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>60505-4327-1</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (60505-4327-1) </PackageDescription>
<NDC11Code>60505-4327-01</NDC11Code>
<ProductNDC>60505-4327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208453</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is:. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>60505-4764-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6) </PackageDescription>
<NDC11Code>60505-4764-06</NDC11Code>
<ProductNDC>60505-4764</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212462</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate is indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H 33NO2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg film-coated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose PH101, and sodium lauryl sulfate. The coating, Opadry® 85F100098-CN Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60687-455-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-455-21) / 1 TABLET in 1 BLISTER PACK (60687-455-11) </PackageDescription>
<NDC11Code>60687-0455-21</NDC11Code>
<ProductNDC>60687-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>60687-790-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (60687-790-21) / 1 TABLET in 1 BLISTER PACK (60687-790-11) </PackageDescription>
<NDC11Code>60687-0790-21</NDC11Code>
<ProductNDC>60687-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>64679-021-01</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (64679-021-01) </PackageDescription>
<NDC11Code>64679-0021-01</NDC11Code>
<ProductNDC>64679-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208380</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with: 1 Metastatic castration-resistant prostate cancer (CRPC)., 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β) -17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water, soluble in methanol and chloroform. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>64980-418-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (64980-418-12) </PackageDescription>
<NDC11Code>64980-0418-12</NDC11Code>
<ProductNDC>64980-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208371</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
</NDCList>