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    NDC 00006-0081-14 JANUMET 1000; 100 mg/1; mg/1 Details

    JANUMET 1000; 100 mg/1; mg/1

    JANUMET is a ORAL TABLET, FILM COATED, EXTENDED RELEASE 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 00006-0081
    Product ID 0006-0081_40b87f24-8005-4ee7-b162-94690443fdb0
    Associated GPIs 27992502707540
    GCN Sequence Number 068540
    GCN Sequence Number Description sitagliptin phos/metformin HCl TBMP 24HR 100-1000MG ORAL
    HIC3 C4F
    HIC3 Description ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS.
    GCN 31348
    HICL Sequence Number 034665
    HICL Sequence Number Description SITAGLIPTIN PHOSPHATE/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name JANUMET
    Proprietary Name Suffix XR
    Non-Proprietary Name sitagliptin and metformin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 1000; 100
    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 NDA202270
    Listing Certified Through 2024-12-31

    Package

    NDC 00006-0081-14 (00006008114)

    NDC Package Code 0006-0081-14
    Billing NDC 00006008114
    Package 2 BOTTLE in 1 CARTON (0006-0081-14) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-07)
    Marketing Start Date 2012-02-02
    NDC Exclude Flag N
    Pricing Information N/A