NDC 70010-492

Metformin

Metformin Er 750 Mg

Metformin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Granules Pharmaceuticals Inc.. The primary component is Metformin Hydrochloride.

Product ID70010-492_3c25fd44-75e2-4cc3-8aeb-d11d957f8b67
NDC70010-492
Product TypeHuman Prescription Drug
Proprietary NameMetformin
Generic NameMetformin Er 750 Mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-18
Marketing CategoryANDA / ANDA
Application NumberANDA209313
Labeler NameGranules Pharmaceuticals Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength750 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70010-492-01

100 TABLET in 1 BOTTLE (70010-492-01)
Marketing Start Date2019-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70010-492-20 [70010049220]

Metformin TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-18

NDC 70010-492-05 [70010049205]

Metformin TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-18

NDC 70010-492-09 [70010049209]

Metformin TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-16

NDC 70010-492-01 [70010049201]

Metformin TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-18

NDC 70010-492-21 [70010049221]

Metformin TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE750 mg/1

OpenFDA Data

SPL SET ID:6d6ee6f8-9650-ff4f-e053-2991aa0acf19
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860981
  • 860975
    • UPC Code
  • 0370010491106
  • 0370010491014

    • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

    NDC Crossover Matching brand name "Metformin" or generic name "Metformin Er 750 Mg"

    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
    62207-492Metformin ER 750 mgMetformin ER 750 mg
    0378-6001Metformin Hydrochloridemetformin
    0378-6002Metformin Hydrochloridemetformin
    65162-174Metformin HydrochlorideMetformin
    65162-175Metformin HydrochlorideMetformin
    65162-177Metformin HydrochlorideMetformin
    0615-8105Metformin HydrochorideMetformin
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