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    NDC 00378-4705-77 Saxagliptin 2.5 mg/1 Details

    Saxagliptin 2.5 mg/1

    Saxagliptin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE.

    Product Information

    NDC 00378-4705
    Product ID 0378-4705_532191af-6300-4246-b459-734e49f21c86
    Associated GPIs
    GCN Sequence Number 065430
    GCN Sequence Number Description saxagliptin HCl TABLET 2.5 MG ORAL
    HIC3 C4J
    HIC3 Description ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS
    GCN 27393
    HICL Sequence Number 036471
    HICL Sequence Number Description SAXAGLIPTIN HCL
    Brand/Generic Generic
    Proprietary Name Saxagliptin
    Proprietary Name Suffix n/a
    Non-Proprietary Name saxagliptin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 2.5
    Active Ingredient Units mg/1
    Substance Name SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
    Labeler Name Mylan Pharmaceuticals Inc.
    Pharmaceutical Class Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205980
    Listing Certified Through 2024-12-31

    Package

    NDC 00378-4705-77 (00378470577)

    NDC Package Code 0378-4705-77
    Billing NDC 00378470577
    Package 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77)
    Marketing Start Date 2023-08-04
    NDC Exclude Flag N
    Pricing Information N/A