metformin hydrochloride

Generic: metformin hydrochloride

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-174
Product ID 82009-174_42cb62ed-35dd-431a-82b7-89d17b0f26af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203686
Listing Expiration 2026-12-31
Marketing Start 2025-07-18

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009174
Hyphenated Format 82009-174

Supplemental Identifiers

RxCUI
861004 861007
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 ANDA203686 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (82009-174-10)
source: ndc

Packages (1)

82009-174-10 1000 TABLET, FILM COATED in 1 BOTTLE (82009-174-10)

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": "42cb62ed-35dd-431a-82b7-89d17b0f26af", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007"], "spl_set_id": ["25be863d-490c-47f6-9ad3-c828dc43fbf0"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (82009-174-10)", "package_ndc": "82009-174-10", "marketing_start_date": "20250718"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "82009-174_42cb62ed-35dd-431a-82b7-89d17b0f26af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "82009-174", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA203686", "marketing_category": "ANDA", "marketing_start_date": "20250718", "listing_expiration_date": "20261231"}