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    NDC 68462-0304-05 Norethindrone Acetate 5 mg/1 Details

    Norethindrone Acetate 5 mg/1

    Norethindrone Acetate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is NORETHINDRONE ACETATE.

    Product Information

    NDC 68462-0304
    Product ID 68462-304_a52ea7a3-e37e-42f7-9519-63b85c663931
    Associated GPIs 26000030100305
    GCN Sequence Number 003274
    GCN Sequence Number Description norethindrone acetate TABLET 5 MG ORAL
    HIC3 G2A
    HIC3 Description PROGESTATIONAL AGENTS
    GCN 11280
    HICL Sequence Number 001443
    HICL Sequence Number Description NORETHINDRONE ACETATE
    Brand/Generic Generic
    Proprietary Name Norethindrone Acetate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Norethindrone Acetate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name NORETHINDRONE ACETATE
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091090
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0304-05 (68462030405)

    NDC Package Code 68462-304-05
    Billing NDC 68462030405
    Package 500 TABLET in 1 BOTTLE (68462-304-05)
    Marketing Start Date 2010-07-21
    NDC Exclude Flag N
    Pricing Information N/A