NDC 64679-021

Abiraterone acetate

Abiraterone Acetate

Abiraterone acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Usa Llc.. The primary component is Abiraterone Acetate.

Product ID64679-021_6a5aa169-f0f0-432b-b0d2-4f5f0a491cec
NDC64679-021
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone acetate
Generic NameAbiraterone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-27
Marketing CategoryANDA / ANDA
Application NumberANDA208380
Labeler NameWockhardt USA LLC.
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 64679-021-01

120 TABLET in 1 BOTTLE (64679-021-01)
Marketing Start Date2019-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64679-021-01 [64679002101]

Abiraterone acetate TABLET
Marketing CategoryANDA
Application NumberANDA208380
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-27

Drug Details

Active Ingredients

IngredientStrength
ABIRATERONE ACETATE250 mg/1

OpenFDA Data

SPL SET ID:76f9bb2f-4946-4391-9e7d-e4f867cf84db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100075
  • UPC Code
  • 0364679021019
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.