metformin hydrochloride

Generic: metformin hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-389
Product ID 29300-389_b816ed37-e579-43a1-9b34-2bb3675eb1c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213359
Listing Expiration 2026-12-31
Marketing Start 2021-08-11

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300389
Hyphenated Format 29300-389

Supplemental Identifiers

RxCUI
860975 860981
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 ANDA213359 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-10)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-19)
source: ndc

Packages (4)

29300-389-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-01) 29300-389-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-05) 29300-389-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-10) 29300-389-19 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-19)

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": "b816ed37-e579-43a1-9b34-2bb3675eb1c2", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["9eebed09-2562-4d21-b3b3-c06562fe3f99"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-01)", "package_ndc": "29300-389-01", "marketing_start_date": "20210811"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-05)", "package_ndc": "29300-389-05", "marketing_start_date": "20210811"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-10)", "package_ndc": "29300-389-10", "marketing_start_date": "20210811"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-19)", "package_ndc": "29300-389-19", "marketing_start_date": "20210811"}], "brand_name": "Metformin Hydrochloride", "product_id": "29300-389_b816ed37-e579-43a1-9b34-2bb3675eb1c2", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "29300-389", "generic_name": "Metformin Hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA213359", "marketing_category": "ANDA", "marketing_start_date": "20210811", "listing_expiration_date": "20261231"}