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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-632
Product ID 42806-632_1b4daf1d-a7a9-8fd1-e063-6294a90a817e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211052
Listing Expiration 2026-12-31
Marketing Start 2020-07-08

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806632
Hyphenated Format 42806-632

Supplemental Identifiers

RxCUI
860975 860981
UPC
0342806632017 0342806633106 0342806633014 0342806632109 0342806633052 0342806632055
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 ANDA211052 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-10)
source: ndc

Packages (3)

42806-632-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-01) 42806-632-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-05) 42806-632-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-10)

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": "1b4daf1d-a7a9-8fd1-e063-6294a90a817e", "openfda": {"upc": ["0342806632017", "0342806633106", "0342806633014", "0342806632109", "0342806633052", "0342806632055"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["a9e7608f-540c-d90c-e053-2a95a90a4f98"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-01)", "package_ndc": "42806-632-01", "marketing_start_date": "20200708"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-05)", "package_ndc": "42806-632-05", "marketing_start_date": "20200708"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-632-10)", "package_ndc": "42806-632-10", "marketing_start_date": "20200708"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "42806-632_1b4daf1d-a7a9-8fd1-e063-6294a90a817e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42806-632", "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": "ANDA211052", "marketing_category": "ANDA", "marketing_start_date": "20200708", "listing_expiration_date": "20261231"}