NDC 0378-6920

Abiraterone Acetate

Abiraterone Acetate

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

Product ID0378-6920_03a01309-f4b8-44fd-8778-166d32cde663
NDC0378-6920
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone Acetate
Generic NameAbiraterone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA208446
Labeler NameMylan 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 0378-6920-78

120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78)
Marketing Start Date2018-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6920-78 [00378692078]

Abiraterone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA208446
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-21

NDC 0378-6920-37 [00378692037]

Abiraterone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA208446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-01
Marketing End Date2019-05-30

Drug Details

Active Ingredients

IngredientStrength
ABIRATERONE ACETATE250 mg/1

OpenFDA Data

SPL SET ID:fe02db79-fa04-441f-b514-70bd74af6624
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 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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