NDC 0143-9597

Abiraterone

Abiraterone Acetate

Abiraterone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Abiraterone Acetate.

Product ID0143-9597_3835de58-63ed-49f3-8f33-d6273d3f8e6c
NDC0143-9597
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone
Generic NameAbiraterone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-23
Marketing CategoryANDA / ANDA
Application NumberANDA208339
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameABIRATERONE ACETATE
Active Ingredient Strength250 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 0143-9597-21

120 TABLET in 1 BOTTLE (0143-9597-21)
Marketing Start Date2018-11-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9597-21 [00143959721]

Abiraterone TABLET
Marketing CategoryANDA
Application NumberANDA208339
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-23

Drug Details

Active Ingredients

IngredientStrength
ABIRATERONE ACETATE250 mg/1

OpenFDA Data

SPL SET ID:be29365a-ed25-44c0-9818-e9016dc95ba6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100075

    • 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" or generic name "Abiraterone Acetate"

    NDCBrand NameGeneric Name
    0143-9597AbirateroneAbiraterone acetate
    69539-049AbirateroneAbiraterone
    72205-030AbirateroneAbiraterone
    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
    47335-401YONSAabiraterone acetate
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