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    NDC 29033-0057-01 Theophylline 100 mg/1 Details

    Theophylline 100 mg/1

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

    Product Information

    NDC 29033-0057
    Product ID 29033-057_90d06aba-2957-49b2-ac92-8af86d2681cd
    Associated GPIs
    GCN Sequence Number 000090
    GCN Sequence Number Description theophylline anhydrous TAB ER 12H 100 MG ORAL
    HIC3 A1B
    HIC3 Description XANTHINES
    GCN 00410
    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 100
    Active Ingredient Units mg/1
    Substance Name THEOPHYLLINE ANHYDROUS
    Labeler Name Nostrum Laboratories, Inc.
    Pharmaceutical Class Methylxanthine [EPC], Xanthines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA087400
    Listing Certified Through 2024-12-31

    Package

    NDC 29033-0057-01 (29033005701)

    NDC Package Code 29033-057-01
    Billing NDC 29033005701
    Package 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-057-01)
    Marketing Start Date 2023-08-16
    NDC Exclude Flag N
    Pricing Information N/A