Search by Drug Name or NDC

    NDC 60219-2045-03 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 Amneal Pharmaceuticals NY LLC. The primary component is THEOPHYLLINE ANHYDROUS.

    Product Information

    NDC 60219-2045
    Product ID 60219-2045_8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf
    Associated GPIs
    GCN Sequence Number 000093
    GCN Sequence Number Description theophylline anhydrous TAB ER 12H 300 MG ORAL
    HIC3 A1B
    HIC3 Description XANTHINES
    GCN 00413
    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 300
    Active Ingredient Units mg/1
    Substance Name THEOPHYLLINE ANHYDROUS
    Labeler Name Amneal Pharmaceuticals NY LLC
    Pharmaceutical Class Methylxanthine [EPC], Xanthines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA216276
    Listing Certified Through 2024-12-31

    Package

    NDC 60219-2045-03 (60219204503)

    NDC Package Code 60219-2045-3
    Billing NDC 60219204503
    Package 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-3)
    Marketing Start Date 2023-03-27
    NDC Exclude Flag N
    Pricing Information N/A