metformin hydrochloride

Generic: metformin hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler micro labs limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-333
Product ID 42571-333_46836128-22ce-1c77-e063-6294a90a9768
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212448
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571333
Hyphenated Format 42571-333

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0342571334901 0342571333010
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 ANDA212448 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-05)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-60)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-90)
source: ndc

Packages (4)

42571-333-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-01) 42571-333-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-05) 42571-333-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-60) 42571-333-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-90)

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": "46836128-22ce-1c77-e063-6294a90a9768", "openfda": {"upc": ["0342571334901", "0342571333010"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["cc070735-5e8d-4bb3-9caa-e84d29bb8943"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-01)", "package_ndc": "42571-333-01", "marketing_start_date": "20230301"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-05)", "package_ndc": "42571-333-05", "marketing_start_date": "20230301"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-60)", "package_ndc": "42571-333-60", "marketing_start_date": "20230301"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-90)", "package_ndc": "42571-333-90", "marketing_start_date": "20230301"}], "brand_name": "Metformin Hydrochloride", "product_id": "42571-333_46836128-22ce-1c77-e063-6294a90a9768", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42571-333", "generic_name": "Metformin Hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA212448", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}