metformin hydrochloride

Generic: metformin hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-313
Product ID 42806-313_b7b6b188-b148-4c9f-8e7b-1fad061209ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2017-03-13

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806313
Hyphenated Format 42806-313

Supplemental Identifiers

RxCUI
861004 861007 861010
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-313-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42806-313-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42806-313-10)
source: ndc

Packages (3)

42806-313-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-313-01) 42806-313-05 500 TABLET, FILM COATED in 1 BOTTLE (42806-313-05) 42806-313-10 1000 TABLET, FILM COATED in 1 BOTTLE (42806-313-10)

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": "b7b6b188-b148-4c9f-8e7b-1fad061209ea", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["8c1848f9-c113-4552-b6ef-715e72630ad9"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-313-01)", "package_ndc": "42806-313-01", "marketing_start_date": "20170313"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42806-313-05)", "package_ndc": "42806-313-05", "marketing_start_date": "20170313"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42806-313-10)", "package_ndc": "42806-313-10", "marketing_start_date": "20170313"}], "brand_name": "Metformin Hydrochloride", "product_id": "42806-313_b7b6b188-b148-4c9f-8e7b-1fad061209ea", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42806-313", "generic_name": "Metformin Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20170313", "listing_expiration_date": "20261231"}