metformin

Generic: metformin er 500 mg

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin
Generic Name metformin er 500 mg
Labeler granules pharmaceuticals inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-491
Product ID 70010-491_451bc376-d523-ee84-e063-6394a90a4743
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209313
Listing Expiration 2026-12-31
Marketing Start 2018-07-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010491
Hyphenated Format 70010-491

Supplemental Identifiers

RxCUI
860975 860981
UPC
0370010492035 0370010491038
UNII
786Z46389E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name metformin (source: ndc)
Generic Name metformin er 500 mg (source: ndc)
Application Number ANDA209313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10)
  • 5000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18)
  • 25000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19)
source: ndc

Packages (6)

70010-491-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01) 70010-491-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05) 70010-491-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09) 70010-491-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10) 70010-491-18 5000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18) 70010-491-19 25000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451bc376-d523-ee84-e063-6394a90a4743", "openfda": {"upc": ["0370010492035", "0370010491038"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["6d6ee6f8-9650-ff4f-e053-2991aa0acf19"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01)", "package_ndc": "70010-491-01", "marketing_start_date": "20180731"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05)", "package_ndc": "70010-491-05", "marketing_start_date": "20180731"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09)", "package_ndc": "70010-491-09", "marketing_start_date": "20200416"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10)", "package_ndc": "70010-491-10", "marketing_start_date": "20180731"}, {"sample": false, "description": "5000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18)", "package_ndc": "70010-491-18", "marketing_start_date": "20190614"}, {"sample": false, "description": "25000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19)", "package_ndc": "70010-491-19", "marketing_start_date": "20190614"}], "brand_name": "Metformin", "product_id": "70010-491_451bc376-d523-ee84-e063-6394a90a4743", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "70010-491", "generic_name": "Metformin ER 500 mg", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209313", "marketing_category": "ANDA", "marketing_start_date": "20180731", "listing_expiration_date": "20261231"}