NDC 64980-418

Abiraterone acetate

Abiraterone Acetate

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

Product ID64980-418_aba84da7-197d-4268-9f0e-b8b28213ddcd
NDC64980-418
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone acetate
Generic NameAbiraterone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-25
Marketing CategoryANDA / ANDA
Application NumberANDA208371
Labeler NameRising Pharmaceuticals, 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 64980-418-12

120 TABLET in 1 BOTTLE (64980-418-12)
Marketing Start Date2019-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-418-12 [64980041812]

Abiraterone acetate TABLET
Marketing CategoryANDA
Application NumberANDA208371
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-25

Drug Details

Active Ingredients

IngredientStrength
ABIRATERONE ACETATE250 mg/1

OpenFDA Data

SPL SET ID:54ae5ef9-aea5-484a-a473-863b1397e206
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]
    • 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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