NDC 50742-634

Metformin

Metformin

Metformin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Metformin Hydrochloride.

Product ID50742-634_7413d37f-1259-4763-88f1-210587dcd646
NDC50742-634
Product TypeHuman Prescription Drug
Proprietary NameMetformin
Generic NameMetformin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA209674
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC], Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50742-634-10

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-10)
Marketing Start Date2018-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-634-30 [50742063430]

Metformin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209674
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-10

NDC 50742-634-60 [50742063460]

Metformin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209674
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-10

NDC 50742-634-10 [50742063410]

Metformin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209674
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-10

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:49a0b5c2-ebaf-4c4c-905f-dfd1962ac647
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1807917
  • 1807894
    • UPC Code
  • 0350742634606
  • 0350742633609

    • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]
    • Biguanide [EPC]
    • Biguanides [CS]

    Medicade Reported Pricing

    50742063460 METFORMIN ER 1,000 MG OSM-TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Metformin" or generic name "Metformin"

    NDCBrand NameGeneric Name
    50742-633Metforminmetformin
    50742-634Metforminmetformin
    68071-2779MetforminMetformin ER 500 mg
    68645-595MetforminMetformin ER 500 mg
    70010-491MetforminMetformin ER 500 mg
    70010-492MetforminMetformin ER 750 mg
    70518-3570MetforminMetformin ER 500 mg
    71610-613MetforminMetformin ER 500 mg
    0378-6001Metformin Hydrochloridemetformin
    0378-6002Metformin Hydrochloridemetformin
    65162-174Metformin HydrochlorideMetformin
    65162-175Metformin HydrochlorideMetformin
    65162-177Metformin HydrochlorideMetformin
    0615-8105Metformin HydrochorideMetformin
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