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    NDC 00310-6105-95 ONGLYZA 5 mg/1 Details

    ONGLYZA 5 mg/1

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

    Product Information

    NDC 00310-6105
    Product ID 0310-6105_71dbfa65-f758-4352-82af-f6fedd8f2242
    Associated GPIs 27550065100330
    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 Brand
    Proprietary Name ONGLYZA
    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 AstraZeneca Pharmaceuticals LP
    Pharmaceutical Class Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022350
    Listing Certified Through 2024-12-31

    Package

    NDC 00310-6105-95 (00310610595)

    NDC Package Code 0310-6105-95
    Billing NDC 00310610595
    Package 1 BLISTER PACK in 1 CARTON (0310-6105-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2015-08-15
    NDC Exclude Flag N
    Pricing Information N/A