metformin hydrochloride

Generic: metformin hydrochloride

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-300
Product ID 68645-300_474350e4-2e45-bec1-e063-6294a90a1154
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077095
Listing Expiration 2026-12-31
Marketing Start 2012-01-13

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68645300
Hyphenated Format 68645-300

Supplemental Identifiers

RxCUI
861004
UPC
0368645300597
UNII
786Z46389E

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 ANDA077095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (68645-300-59)
source: ndc

Packages (1)

68645-300-59 60 TABLET, FILM COATED in 1 BOTTLE (68645-300-59)

Ingredients (1)

metformin hydrochloride (1000 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": "474350e4-2e45-bec1-e063-6294a90a1154", "openfda": {"upc": ["0368645300597"], "unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["3814cfed-029f-4231-bba3-89b2b4e01392"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68645-300-59)", "package_ndc": "68645-300-59", "marketing_start_date": "20120113"}], "brand_name": "Metformin Hydrochloride", "product_id": "68645-300_474350e4-2e45-bec1-e063-6294a90a1154", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68645-300", "generic_name": "Metformin Hydrochloride", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA077095", "marketing_category": "ANDA", "marketing_start_date": "20120113", "listing_expiration_date": "20261231"}