metformin hcl

Generic: metformin hcl

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hcl
Generic Name metformin hcl
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-049
Product ID 82868-049_46dcc055-d88e-a2c8-e063-6294a90a2ed4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2024-02-21

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868049
Hyphenated Format 82868-049

Supplemental Identifiers

RxCUI
861007
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 hcl (source: ndc)
Generic Name metformin hcl (source: ndc)
Application Number ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (82868-049-90)
  • 120 TABLET in 1 BOTTLE, PLASTIC (82868-049-98)
source: ndc

Packages (2)

82868-049-90 90 TABLET in 1 BOTTLE, PLASTIC (82868-049-90) 82868-049-98 120 TABLET in 1 BOTTLE, PLASTIC (82868-049-98)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46dcc055-d88e-a2c8-e063-6294a90a2ed4", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["13b1e35f-d047-8ddc-e063-6394a90a24dd"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (82868-049-90)", "package_ndc": "82868-049-90", "marketing_start_date": "20240325"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (82868-049-98)", "package_ndc": "82868-049-98", "marketing_start_date": "20240221"}], "brand_name": "Metformin HCl", "product_id": "82868-049_46dcc055-d88e-a2c8-e063-6294a90a2ed4", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "82868-049", "generic_name": "Metformin HCl", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin HCl", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20240221", "listing_expiration_date": "20261231"}