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    NDC 51991-0474-28 Estradiol / Norethindrone Acetate 1; .5 mg/1; mg/1 Details

    Estradiol / Norethindrone Acetate 1; .5 mg/1; mg/1

    Estradiol / Norethindrone Acetate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is ESTRADIOL; NORETHINDRONE ACETATE.

    Product Information

    NDC 51991-0474
    Product ID 51991-474_5d019d6f-2bf4-49f4-b539-0bcfd418c42f
    Associated GPIs 24993002120310
    GCN Sequence Number 040888
    GCN Sequence Number Description estradiol/norethindrone acet TABLET 1 MG-0.5MG ORAL
    HIC3 G1A
    HIC3 Description ESTROGENIC AGENTS
    GCN 95046
    HICL Sequence Number 007310
    HICL Sequence Number Description ESTRADIOL/NORETHINDRONE ACETATE
    Brand/Generic Generic
    Proprietary Name Estradiol / Norethindrone Acetate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Estradiol and Norethindrone Acetate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 1; .5
    Active Ingredient Units mg/1; mg/1
    Substance Name ESTRADIOL; NORETHINDRONE ACETATE
    Labeler Name Breckenridge Pharmaceutical, Inc.
    Pharmaceutical Class Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078324
    Listing Certified Through 2024-12-31

    Package

    NDC 51991-0474-28 (51991047428)

    NDC Package Code 51991-474-28
    Billing NDC 51991047428
    Package 1 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2008-04-17
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.86751
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description ESTRADIOL-NORETH 1-0.5 MG TAB
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2024-02-21
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 44125b2f-10ac-435c-bdb4-a29bf8450dbf Details

    Revised: 5/2022