metformin hydrochloride

Generic: metformin hydrochloride

Labeler: granules india ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler granules india ltd
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-496
Product ID 62207-496_414662c8-b86d-4c80-e063-6294a90a3cb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213344
Listing Expiration 2026-12-31
Marketing Start 2021-02-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62207496
Hyphenated Format 62207-496

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0362207496544
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 hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA213344 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-496-47)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-496-54)
source: ndc

Packages (2)

62207-496-47 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-496-47) 62207-496-54 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-496-54)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "414662c8-b86d-4c80-e063-6294a90a3cb0", "openfda": {"upc": ["0362207496544"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["73197cb5-3e23-4ac0-b189-f9bc848bce66"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-496-47)", "package_ndc": "62207-496-47", "marketing_start_date": "20210201"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-496-54)", "package_ndc": "62207-496-54", "marketing_start_date": "20210201"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "62207-496_414662c8-b86d-4c80-e063-6294a90a3cb0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "62207-496", "generic_name": "Metformin Hydrochloride", "labeler_name": "Granules India Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA213344", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}