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    NDC 50090-5504-00 JANUMET 1000; 50 mg/1; mg/1 Details

    JANUMET 1000; 50 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 A-S Medication Solutions. The primary component is METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE.

    Product Information

    NDC 50090-5504
    Product ID 50090-5504_daeedefc-b17c-4c81-8677-dc75b1eb8af2
    Associated GPIs 27992502707530
    GCN Sequence Number 068539
    GCN Sequence Number Description sitagliptin phos/metformin HCl TBMP 24HR 50-1000 MG ORAL
    HIC3 C4F
    HIC3 Description ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS.
    GCN 31340
    HICL Sequence Number 034665
    HICL Sequence Number Description SITAGLIPTIN PHOSPHATE/METFORMIN HCL
    Brand/Generic Generic
    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; 50
    Active Ingredient Units mg/1; mg/1
    Substance Name METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
    Labeler Name A-S Medication Solutions
    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 50090-5504-00 (50090550400)

    NDC Package Code 50090-5504-0
    Billing NDC 50090550400
    Package 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0)
    Marketing Start Date 2021-03-31
    NDC Exclude Flag N
    Pricing Information N/A