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    NDC 00480-3309-01 Theophylline 450 mg/1 Details

    Theophylline 450 mg/1

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

    Product Information

    NDC 00480-3309
    Product ID 0480-3309_287dcdda-ce6b-4949-bf12-4316f1f4fe00
    Associated GPIs
    GCN Sequence Number 000095
    GCN Sequence Number Description theophylline anhydrous TAB ER 12H 450 MG ORAL
    HIC3 A1B
    HIC3 Description XANTHINES
    GCN 00416
    HICL Sequence Number 000025
    HICL Sequence Number Description THEOPHYLLINE ANHYDROUS
    Brand/Generic Generic
    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 450
    Active Ingredient Units mg/1
    Substance Name THEOPHYLLINE
    Labeler Name Teva Pharmaceuticals, Inc.
    Pharmaceutical Class Methylxanthine [EPC], Xanthines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA216961
    Listing Certified Through 2024-12-31

    Package

    NDC 00480-3309-01 (00480330901)

    NDC Package Code 0480-3309-01
    Billing NDC 00480330901
    Package 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3309-01)
    Marketing Start Date 2023-01-27
    NDC Exclude Flag N
    Pricing Information N/A