metformin hydrochloride

Generic: metformin hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-218
Product ID 53746-218_87735a77-fc44-4fb2-b8f4-1dc44d13ad0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077880
Listing Expiration 2026-12-31
Marketing Start 2012-12-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746218
Hyphenated Format 53746-218

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0353746219015 0353746220011 0353746218018
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 ANDA077880 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-218-01)
  • 500 TABLET in 1 BOTTLE (53746-218-05)
  • 1000 TABLET in 1 BOTTLE (53746-218-10)
source: ndc

Packages (3)

53746-218-01 100 TABLET in 1 BOTTLE (53746-218-01) 53746-218-05 500 TABLET in 1 BOTTLE (53746-218-05) 53746-218-10 1000 TABLET in 1 BOTTLE (53746-218-10)

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": "87735a77-fc44-4fb2-b8f4-1dc44d13ad0a", "openfda": {"upc": ["0353746219015", "0353746220011", "0353746218018"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["b090b18b-b53c-4c92-892f-d11551cfedc3"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-218-01)", "package_ndc": "53746-218-01", "marketing_start_date": "20121217"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-218-05)", "package_ndc": "53746-218-05", "marketing_start_date": "20121217"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-218-10)", "package_ndc": "53746-218-10", "marketing_start_date": "20121217"}], "brand_name": "Metformin Hydrochloride", "product_id": "53746-218_87735a77-fc44-4fb2-b8f4-1dc44d13ad0a", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "53746-218", "generic_name": "Metformin Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077880", "marketing_category": "ANDA", "marketing_start_date": "20121217", "listing_expiration_date": "20261231"}