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    NDC 10135-0745-62 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 Marlex Pharmaceuticals, Inc.. The primary component is MISOPROSTOL.

    Product Information

    NDC 10135-0745
    Product ID 10135-745_f5f0e042-f033-4f3c-e053-2995a90a375f
    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 Marlex Pharmaceuticals, Inc.
    Pharmaceutical Class Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076095
    Listing Certified Through 2024-12-31

    Package

    NDC 10135-0745-62 (10135074562)

    NDC Package Code 10135-745-62
    Billing NDC 10135074562
    Package 120 TABLET in 1 BOTTLE (10135-745-62)
    Marketing Start Date 2022-06-01
    NDC Exclude Flag N
    Pricing Information N/A