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    NDC 69543-0372-10 Prometrium 100 mg/1 Details

    Prometrium 100 mg/1

    Prometrium is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Virtus Pharmaceuticals. The primary component is PROGESTERONE.

    Product Information

    NDC 69543-0372
    Product ID 69543-372_5ddff444-38c1-455f-a911-bd5d31f56275
    Associated GPIs 26000040000120
    GCN Sequence Number 043801
    GCN Sequence Number Description progesterone, micronized CAPSULE 100 MG ORAL
    HIC3 G2A
    HIC3 Description PROGESTATIONAL AGENTS
    GCN 50776
    HICL Sequence Number 020653
    HICL Sequence Number Description PROGESTERONE, MICRONIZED
    Brand/Generic Brand
    Proprietary Name Prometrium
    Proprietary Name Suffix n/a
    Non-Proprietary Name Progesterone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name PROGESTERONE
    Labeler Name Virtus Pharmaceuticals
    Pharmaceutical Class Progesterone [CS], Progesterone [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA019781
    Listing Certified Through 2024-12-31

    Package

    NDC 69543-0372-10 (69543037210)

    NDC Package Code 69543-372-10
    Billing NDC 69543037210
    Package 100 CAPSULE in 1 BOTTLE (69543-372-10)
    Marketing Start Date 2016-07-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a451784e-f6a0-414a-8409-3407f1d1d086 Details

    Revised: 10/2022