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    NDC 00006-0575-03 JANUMET 500; 50 mg/1; mg/1 Details

    JANUMET 500; 50 mg/1; mg/1

    JANUMET is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE.

    Product Information

    NDC 00006-0575
    Product ID 0006-0575_57ef5ead-02e0-417d-b21f-8e41ff34b53f
    Associated GPIs 27992502700320
    GCN Sequence Number 062531
    GCN Sequence Number Description sitagliptin phos/metformin HCl TABLET 50MG-500MG ORAL
    HIC3 C4F
    HIC3 Description ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS.
    GCN 98306
    HICL Sequence Number 034665
    HICL Sequence Number Description SITAGLIPTIN PHOSPHATE/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name JANUMET
    Proprietary Name Suffix n/a
    Non-Proprietary Name SITAGLIPTIN and METFORMIN HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 500; 50
    Active Ingredient Units mg/1; mg/1
    Substance Name METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
    Labeler Name Merck Sharp & Dohme LLC
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022044
    Listing Certified Through 2024-12-31

    Package

    NDC 00006-0575-03 (00006057503)

    NDC Package Code 0006-0575-03
    Billing NDC 00006057503
    Package 2 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02)
    Marketing Start Date 2007-03-30
    NDC Exclude Flag N
    Pricing Information N/A