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    NDC 72789-0121-08 Misoprostol 100 ug/1 Details

    Misoprostol 100 ug/1

    Misoprostol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is MISOPROSTOL.

    Product Information

    NDC 72789-0121
    Product ID 72789-121_0631d5e5-9da6-bcb7-e063-6394a90a62de
    Associated GPIs 49250030000310
    GCN Sequence Number 015197
    GCN Sequence Number Description misoprostol TABLET 100 MCG ORAL
    HIC3 D4E
    HIC3 Description ANTI-ULCER PREPARATIONS
    GCN 08251
    HICL Sequence Number 001187
    HICL Sequence Number Description MISOPROSTOL
    Brand/Generic Generic
    Proprietary Name Misoprostol
    Proprietary Name Suffix n/a
    Non-Proprietary Name Misoprostol
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units ug/1
    Substance Name MISOPROSTOL
    Labeler Name PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091667
    Listing Certified Through 2024-12-31

    Package

    NDC 72789-0121-08 (72789012108)

    NDC Package Code 72789-121-08
    Billing NDC 72789012108
    Package 8 TABLET in 1 BOTTLE, PLASTIC (72789-121-08)
    Marketing Start Date 2020-09-24
    NDC Exclude Flag N
    Pricing Information N/A