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    NDC 46708-0025-71 Theophylline 300 mg/1 Details

    Theophylline 300 mg/1

    Theophylline is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is THEOPHYLLINE ANHYDROUS.

    Product Information

    NDC 46708-0025
    Product ID 46708-025_0d340b17-907e-4c38-bbd6-c4740495a55a
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Theophylline
    Proprietary Name Suffix n/a
    Non-Proprietary Name Theophylline
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 300
    Active Ingredient Units mg/1
    Substance Name THEOPHYLLINE ANHYDROUS
    Labeler Name Alembic Pharmaceuticals Limited
    Pharmaceutical Class Methylxanthine [EPC], Xanthines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090430
    Listing Certified Through 2024-12-31

    Package

    NDC 46708-0025-71 (46708002571)

    NDC Package Code 46708-025-71
    Billing NDC 46708002571
    Package 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-71)
    Marketing Start Date 2010-11-01
    NDC Exclude Flag N
    Pricing Information N/A