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    NDC 65162-0475-03 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 Amneal Pharmaceuticals LLC. The primary component is NORETHINDRONE ACETATE.

    Product Information

    NDC 65162-0475
    Product ID 65162-475_24aef00c-bbdf-4c6b-b260-ade5a3f8cc82
    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
    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 Amneal Pharmaceuticals LLC
    Pharmaceutical Class Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA200275
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0475-03 (65162047503)

    NDC Package Code 65162-475-03
    Billing NDC 65162047503
    Package 30 TABLET in 1 BOTTLE (65162-475-03)
    Marketing Start Date 2009-07-01
    NDC Exclude Flag N
    Pricing Information N/A