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 68071-3531
Product ID 68071-3531_2d3f9c43-31df-2883-e063-6294a90a7742
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213320
Listing Expiration 2026-12-31
Marketing Start 2023-01-19

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713531
Hyphenated Format 68071-3531

Supplemental Identifiers

RxCUI
861010
UPC
0368071353112
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 ANDA213320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68071-3531-1)
source: ndc

Packages (1)

68071-3531-1 100 TABLET in 1 BOTTLE (68071-3531-1)

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": "2d3f9c43-31df-2883-e063-6294a90a7742", "openfda": {"upc": ["0368071353112"], "unii": ["786Z46389E"], "rxcui": ["861010"], "spl_set_id": ["0b3d5420-d60c-8385-e063-6394a90abb6c"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68071-3531-1)", "package_ndc": "68071-3531-1", "marketing_start_date": "20231128"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68071-3531_2d3f9c43-31df-2883-e063-6294a90a7742", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68071-3531", "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": "ANDA213320", "marketing_category": "ANDA", "marketing_start_date": "20230119", "listing_expiration_date": "20261231"}