metformin hydrochloride

Generic: metformin hydrochloride

Labeler: solco healthcare us, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler solco healthcare us, llc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Solco Healthcare US, LLC.

Identifiers & Regulatory

Product NDC 43547-504
Product ID 43547-504_1016cad7-2198-483c-893b-e25fd397a226
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212681
Listing Expiration 2026-12-31
Marketing Start 2022-05-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547504
Hyphenated Format 43547-504

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0343547504090
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 ANDA212681 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-09)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-50)
source: ndc

Packages (2)

43547-504-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-09) 43547-504-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-50)

Ingredients (1)

metformin hydrochloride (1000 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": "1016cad7-2198-483c-893b-e25fd397a226", "openfda": {"upc": ["0343547504090"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["1016cad7-2198-483c-893b-e25fd397a226"], "manufacturer_name": ["Solco Healthcare US, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-09)", "package_ndc": "43547-504-09", "marketing_start_date": "20220531"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-50)", "package_ndc": "43547-504-50", "marketing_start_date": "20220531"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "43547-504_1016cad7-2198-483c-893b-e25fd397a226", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "43547-504", "generic_name": "metformin hydrochloride", "labeler_name": "Solco Healthcare US, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA212681", "marketing_category": "ANDA", "marketing_start_date": "20220531", "listing_expiration_date": "20261231"}