metformin

Generic: metformin er 500 mg

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

Drug Facts

Product Profile

Brand Name metformin
Generic Name metformin er 500 mg
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-595
Product ID 68645-595_26f9c8ba-2913-ff5e-e063-6294a90a033d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209313
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68645595
Hyphenated Format 68645-595

Supplemental Identifiers

RxCUI
860975
UPC
0368645595597
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 (source: ndc)
Generic Name metformin er 500 mg (source: ndc)
Application Number ANDA209313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68645-595-59)
source: ndc

Packages (1)

68645-595-59 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68645-595-59)

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": "26f9c8ba-2913-ff5e-e063-6294a90a033d", "openfda": {"upc": ["0368645595597"], "unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["d9e0816d-fd61-1ac2-e053-2995a90a4054"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68645-595-59)", "package_ndc": "68645-595-59", "marketing_start_date": "20220310"}], "brand_name": "Metformin", "product_id": "68645-595_26f9c8ba-2913-ff5e-e063-6294a90a033d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68645-595", "generic_name": "Metformin ER 500 mg", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209313", "marketing_category": "ANDA", "marketing_start_date": "20220310", "listing_expiration_date": "20261231"}