Search by Drug Name or NDC

    NDC 43598-0620-30 Saxagliptin and Metformin Hydrochloride 500; 5 mg/1; mg/1 Details

    Saxagliptin and Metformin Hydrochloride 500; 5 mg/1; mg/1

    Saxagliptin and Metformin Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr.Reddys Laboratories Inc. The primary component is METFORMIN HYDROCHLORIDE; SAXAGLIPTIN.

    Product Information

    NDC 43598-0620
    Product ID 43598-620_bb0a9e92-ffa9-e5ee-51d5-30e6c78fed45
    Associated GPIs
    GCN Sequence Number 066816
    GCN Sequence Number Description saxagliptin HCl/metformin HCl TBMP 24HR 5 MG-500MG ORAL
    HIC3 C4F
    HIC3 Description ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS.
    GCN 29118
    HICL Sequence Number 037246
    HICL Sequence Number Description SAXAGLIPTIN HCL/METFORMIN HCL
    Brand/Generic Generic
    Proprietary Name Saxagliptin and Metformin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Saxagliptin and Metformin Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 500; 5
    Active Ingredient Units mg/1; mg/1
    Substance Name METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
    Labeler Name Dr.Reddys Laboratories Inc
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207678
    Listing Certified Through 2024-12-31

    Package

    NDC 43598-0620-30 (43598062030)

    NDC Package Code 43598-620-30
    Billing NDC 43598062030
    Package 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-620-30)
    Marketing Start Date 2023-08-09
    NDC Exclude Flag N
    Pricing Information N/A