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    NDC 69315-0283-01 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Details

    ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1

    ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharmaceuticals, LLC. The primary component is ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE.

    Product Information

    NDC 69315-0283
    Product ID 69315-283_b0329bda-d477-4eed-815c-1049532e1bb0
    Associated GPIs
    GCN Sequence Number 003257
    GCN Sequence Number Description estrogen,ester/me-testosterone TABLET 0.625-1.25 ORAL
    HIC3 G1B
    HIC3 Description ESTROGEN/ANDROGEN COMBINATIONS
    GCN 68030
    HICL Sequence Number 001438
    HICL Sequence Number Description ESTROGENS,ESTERIFIED/METHYLTESTOSTERONE
    Brand/Generic Generic
    Proprietary Name ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
    Proprietary Name Suffix n/a
    Non-Proprietary Name ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength .625; 1.25
    Active Ingredient Units mg/1; mg/1
    Substance Name ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
    Labeler Name Leading Pharmaceuticals, LLC
    Pharmaceutical Class Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
    DEA Schedule CIII
    Marketing Category UNAPPROVED DRUG OTHER
    Application Number n/a
    Listing Certified Through 2025-12-31

    Package

    NDC 69315-0283-01 (69315028301)

    NDC Package Code 69315-283-01
    Billing NDC 69315028301
    Package 100 TABLET in 1 BOTTLE (69315-283-01)
    Marketing Start Date 2022-10-01
    NDC Exclude Flag N
    Pricing Information N/A