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    NDC 63629-9429-01 Abiraterone Acetate 250 mg/1 Details

    Abiraterone Acetate 250 mg/1

    Abiraterone Acetate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ABIRATERONE ACETATE.

    Product Information

    NDC 63629-9429
    Product ID 63629-9429_e170bba1-a152-43fb-a566-296819ae50f4
    Associated GPIs
    GCN Sequence Number 067349
    GCN Sequence Number Description abiraterone acetate TABLET 250 MG ORAL
    HIC3 V1J
    HIC3 Description ANTINEOPLASTIC - ANTIANDROGENIC AGENTS
    GCN 29886
    HICL Sequence Number 037571
    HICL Sequence Number Description ABIRATERONE ACETATE
    Brand/Generic Generic
    Proprietary Name Abiraterone Acetate
    Proprietary Name Suffix n/a
    Non-Proprietary Name abiraterone acetate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 250
    Active Ingredient Units mg/1
    Substance Name ABIRATERONE ACETATE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215947
    Listing Certified Through 2023-12-31

    Package

    NDC 63629-9429-01 (63629942901)

    NDC Package Code 63629-9429-1
    Billing NDC 63629942901
    Package 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9429-1)
    Marketing Start Date 2022-08-23
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 190ac962-474b-4a80-8bd1-420c7e681b1d Details

    Revised: 8/2022