NDC 62207-492

Metformin ER 750 mg

Metformin Er 750 Mg

Metformin ER 750 mg is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Granules India Ltd. The primary component is Metformin Hydrochloride.

Product ID62207-492_4018761c-a122-4b3a-bf4a-e1a52ee4660c
NDC62207-492
Product TypeHuman Prescription Drug
Proprietary NameMetformin ER 750 mg
Generic NameMetformin Er 750 Mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-28
Marketing CategoryANDA / ANDA
Application NumberANDA209313
Labeler NameGranules India Ltd
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength750 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62207-492-40

3500 TABLET in 1 POUCH (62207-492-40)
Marketing Start Date2018-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62207-492-47 [62207049247]

Metformin ER 750 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 62207-492-43 [62207049243]

Metformin ER 750 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 62207-492-49 [62207049249]

Metformin ER 750 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 62207-492-40 [62207049240]

Metformin ER 750 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-28

NDC 62207-492-74 [62207049274]

Metformin ER 750 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-28

NDC 62207-492-54 [62207049254]

Metformin ER 750 mg 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:b857eccf-b9ff-45ba-8241-f47f5caada2a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860981
  • 860975
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

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

    NDCBrand NameGeneric Name
    62207-492Metformin ER 750 mgMetformin ER 750 mg
    70010-492MetforminMetformin ER 750 mg

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.