metformin hydrochloride

Generic: metformin hydrochloride tablets

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

Drug Facts

Product Profile

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

metformin hydrochloride 500 mg/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-405
Product ID 42806-405_1edb3813-b7cb-4501-ad91-eae58624c836
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209993
Listing Expiration 2027-12-31
Marketing Start 2019-01-04

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806405
Hyphenated Format 42806-405

Supplemental Identifiers

RxCUI
1807894 1807917
UPC
0342806406601 0342806405604
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 tablets (source: ndc)
Application Number ANDA209993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-405-60)
source: ndc

Packages (1)

42806-405-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-405-60)

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": "1edb3813-b7cb-4501-ad91-eae58624c836", "openfda": {"upc": ["0342806406601", "0342806405604"], "unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["356b02d0-d239-4441-bb33-c4c54166fcd7"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-405-60)", "package_ndc": "42806-405-60", "marketing_start_date": "20190104"}], "brand_name": "metformin hydrochloride", "product_id": "42806-405_1edb3813-b7cb-4501-ad91-eae58624c836", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42806-405", "generic_name": "metformin hydrochloride tablets", "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": "ANDA209993", "marketing_category": "ANDA", "marketing_start_date": "20190104", "listing_expiration_date": "20271231"}