metformin

Generic: metformin

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin
Generic Name metformin
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-633
Product ID 50742-633_9f4c61fa-2184-41c1-9438-bd6ab1bfdcbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209674
Listing Expiration 2026-12-31
Marketing Start 2018-12-10

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742633
Hyphenated Format 50742-633

Supplemental Identifiers

RxCUI
1807894 1807917
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 (source: ndc)
Application Number ANDA209674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-10)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-90)
source: ndc

Packages (3)

50742-633-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-10) 50742-633-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-60) 50742-633-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-90)

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": "9f4c61fa-2184-41c1-9438-bd6ab1bfdcbc", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["49a0b5c2-ebaf-4c4c-905f-dfd1962ac647"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-10)", "package_ndc": "50742-633-10", "marketing_start_date": "20181210"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-60)", "package_ndc": "50742-633-60", "marketing_start_date": "20181210"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-90)", "package_ndc": "50742-633-90", "marketing_start_date": "20181210"}], "brand_name": "Metformin", "product_id": "50742-633_9f4c61fa-2184-41c1-9438-bd6ab1bfdcbc", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "50742-633", "generic_name": "metformin", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209674", "marketing_category": "ANDA", "marketing_start_date": "20181210", "listing_expiration_date": "20261231"}