metformin hydrochloride

Generic: metformin hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3495
Product ID 68071-3495_1ef48a70-a4ad-28bf-e063-6394a90a9795
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713495
Hyphenated Format 68071-3495

Supplemental Identifiers

RxCUI
861010
UPC
0368071349580
UNII
786Z46389E

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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (68071-3495-8)
source: ndc

Packages (1)

68071-3495-8 180 TABLET in 1 BOTTLE (68071-3495-8)

Ingredients (1)

metformin hydrochloride (850 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": "1ef48a70-a4ad-28bf-e063-6394a90a9795", "openfda": {"upc": ["0368071349580"], "unii": ["786Z46389E"], "rxcui": ["861010"], "spl_set_id": ["041632fa-9bf4-8d7c-e063-6294a90adefb"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (68071-3495-8)", "package_ndc": "68071-3495-8", "marketing_start_date": "20230829"}], "brand_name": "Metformin Hydrochloride", "product_id": "68071-3495_1ef48a70-a4ad-28bf-e063-6394a90a9795", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68071-3495", "generic_name": "Metformin Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}