metformin hydrochloride

Generic: metformin hydrochloride tablet

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 tablet
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-046
Product ID 82009-046_451e8dd3-039f-4756-e063-6394a90a0483
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2022-02-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009046
Hyphenated Format 82009-046

Supplemental Identifiers

RxCUI
861004 861007
UPC
0382009046105 0382009047102
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 tablet (source: ndc)
Application Number ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (82009-046-10)
source: ndc

Packages (1)

82009-046-10 1000 TABLET in 1 BOTTLE (82009-046-10)

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": "451e8dd3-039f-4756-e063-6394a90a0483", "openfda": {"upc": ["0382009046105", "0382009047102"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007"], "spl_set_id": ["f39ee08d-73db-71b9-e053-2995a90a877c"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (82009-046-10)", "package_ndc": "82009-046-10", "marketing_start_date": "20230201"}], "brand_name": "Metformin Hydrochloride", "product_id": "82009-046_451e8dd3-039f-4756-e063-6394a90a0483", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "82009-046", "generic_name": "Metformin Hydrochloride Tablet", "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": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20220201", "listing_expiration_date": "20261231"}