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    NDC 65162-0060-09 Saxagliptin 5 mg/1 Details

    Saxagliptin 5 mg/1

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

    Product Information

    NDC 65162-0060
    Product ID 65162-060_1bcb5eef-e494-460d-84e9-b4a421fc650d
    Associated GPIs
    GCN Sequence Number 065431
    GCN Sequence Number Description saxagliptin HCl TABLET 5 MG ORAL
    HIC3 C4J
    HIC3 Description ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS
    GCN 27394
    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 5
    Active Ingredient Units mg/1
    Substance Name SAXAGLIPTIN HYDROCHLORIDE
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205941
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0060-09 (65162006009)

    NDC Package Code 65162-060-09
    Billing NDC 65162006009
    Package 90 TABLET, FILM COATED in 1 BOTTLE (65162-060-09)
    Marketing Start Date 2023-08-01
    NDC Exclude Flag N
    Pricing Information N/A