NDC 57894-199

Abiraterone acetate

Abiraterone Acetate

Abiraterone acetate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Abiraterone Acetate.

Product ID57894-199_0d48b90e-7ea7-11e8-8356-45999d46d017
NDC57894-199
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone acetate
Generic NameAbiraterone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-03-05
Marketing CategoryNDA / NDA
Application NumberNDA202379
Labeler NameJanssen Biotech, Inc.
Substance NameABIRATERONE ACETATE
Active Ingredient Strength500 mg/1
Pharm ClassesCytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57894-199-06

60 TABLET, FILM COATED in 1 BOTTLE (57894-199-06)
Marketing Start Date2018-03-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57894-199-06 [57894019906]

Abiraterone acetate TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-05
Marketing End Date2020-01-02

Drug Details

Active Ingredients

IngredientStrength
ABIRATERONE ACETATE500 mg/1

OpenFDA Data

SPL SET ID:48ce18c7-5311-40cb-8903-104eb89b32e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100075
  • 1918042
  • Pharmacological Class

    • Cytochrome P450 17A1 Inhibitors [MoA]
    • Cytochrome P450 17A1 Inhibitor [EPC]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]

    NDC Crossover Matching brand name "Abiraterone acetate" or generic name "Abiraterone Acetate"

    NDCBrand NameGeneric Name
    0093-1125Abiraterone AcetateAbiraterone Acetate
    0378-6920Abiraterone Acetateabiraterone acetate
    0378-6921Abiraterone Acetateabiraterone acetate
    0378-6924Abiraterone Acetateabiraterone acetate
    0904-6948Abiraterone AcetateAbiraterone Acetate
    16714-963Abiraterone AcetateAbiraterone Acetate
    42291-024Abiraterone AcetateAbiraterone
    42291-073ABIRATERONE ACETATEABIRATERONE
    42292-057Abiraterone Acetateabiraterone acetate
    43598-358Abiraterone AcetateAbiraterone Acetate
    69238-1165Abiraterone AcetateAbiraterone Acetate
    51407-181Abiraterone AcetateAbiraterone Acetate
    57894-199Abiraterone acetateAbiraterone acetate
    57894-155Abiraterone acetateAbiraterone acetate
    60505-4327Abiraterone AcetateAbiraterone Acetate
    64679-021Abiraterone acetateAbiraterone acetate
    64980-418Abiraterone acetateAbiraterone acetate
    60687-455Abiraterone AcetateAbiraterone Acetate
    72606-566Abiraterone acetateAbiraterone acetate
    68462-135abiraterone acetateabiraterone acetate
    0143-9597AbirateroneAbiraterone acetate
    47335-401YONSAabiraterone acetate

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