Search by Drug Name or NDC

    NDC 75834-0130-90 Norethindrone Acetate and Ethinyl Estradiol .005; 1 mg/1; mg/1 Details

    Norethindrone Acetate and Ethinyl Estradiol .005; 1 mg/1; mg/1

    Norethindrone Acetate and Ethinyl Estradiol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is ETHINYL ESTRADIOL; NORETHINDRONE ACETATE.

    Product Information

    NDC 75834-0130
    Product ID 75834-130_4ffa902e-2cf8-4160-ba1e-f27e48b8e502
    Associated GPIs 24993002250310
    GCN Sequence Number 044337
    GCN Sequence Number Description norethindrone ac-eth estradiol TABLET 1MG-5MCG ORAL
    HIC3 G1A
    HIC3 Description ESTROGENIC AGENTS
    GCN 92296
    HICL Sequence Number 001455
    HICL Sequence Number Description NORETHINDRONE ACETATE-ETHINYL ESTRADIOL
    Brand/Generic Generic
    Proprietary Name Norethindrone Acetate and Ethinyl Estradiol
    Proprietary Name Suffix n/a
    Non-Proprietary Name Norethindrone Acetate and Ethinyl Estradiol
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength .005; 1
    Active Ingredient Units mg/1; mg/1
    Substance Name ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
    Labeler Name Nivagen Pharmaceuticals, Inc.
    Pharmaceutical Class Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203435
    Listing Certified Through 2024-12-31

    Package

    NDC 75834-0130-90 (75834013090)

    NDC Package Code 75834-130-90
    Billing NDC 75834013090
    Package 90 TABLET in 1 BOTTLE (75834-130-90)
    Marketing Start Date 2016-11-25
    NDC Exclude Flag N
    Pricing Information N/A