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
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-583
Product ID 68645-583_330039dd-ccd8-5a74-e063-6294a90ad1b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2019-06-07

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68645583
Hyphenated Format 68645-583

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0368645582597 0368645583594 0368645584591
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (68645-583-59)
source: ndc

Packages (1)

68645-583-59 60 TABLET in 1 BOTTLE (68645-583-59)

Ingredients (1)

metformin hydrochloride (850 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": "330039dd-ccd8-5a74-e063-6294a90ad1b8", "openfda": {"upc": ["0368645582597", "0368645583594", "0368645584591"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["b51da8d7-ab4a-4c40-97c9-88bd379366d1"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (68645-583-59)", "package_ndc": "68645-583-59", "marketing_start_date": "20190607"}], "brand_name": "Metformin hydrochloride", "product_id": "68645-583_330039dd-ccd8-5a74-e063-6294a90ad1b8", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68645-583", "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": "850 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20190607", "listing_expiration_date": "20261231"}