NDC 62207-491

Metformin ER 500 mg

Metformin Er 500 Mg

Metformin ER 500 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 ID62207-491_4018761c-a122-4b3a-bf4a-e1a52ee4660c
NDC62207-491
Product TypeHuman Prescription Drug
Proprietary NameMetformin ER 500 mg
Generic NameMetformin Er 500 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 Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62207-491-31

5000 TABLET in 1 POUCH (62207-491-31)
Marketing Start Date2018-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62207-491-49 [62207049149]

Metformin ER 500 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 62207-491-47 [62207049147]

Metformin ER 500 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 62207-491-31 [62207049131]

Metformin ER 500 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-28

NDC 62207-491-54 [62207049154]

Metformin ER 500 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 62207-491-35 [62207049135]

Metformin ER 500 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-28

NDC 62207-491-43 [62207049143]

Metformin ER 500 mg TABLET
Marketing CategoryANDA
Application NumberANDA209313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 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 500 mg" or generic name "Metformin Er 500 Mg"

    NDCBrand NameGeneric Name
    62207-491Metformin ER 500 mgMetformin ER 500 mg
    68071-2779MetforminMetformin ER 500 mg
    68645-595MetforminMetformin ER 500 mg
    70010-491MetforminMetformin ER 500 mg
    70518-3570MetforminMetformin ER 500 mg
    71610-613MetforminMetformin ER 500 mg
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