metformin hydrochloride

Generic: metformin hydrochloride

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler mullan pharmaceutical inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0008
Product ID 83301-0008_423f5f82-8524-65aa-e063-6294a90a1180
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205096
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 833010008
Hyphenated Format 83301-0008

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0383301001014 0383301000826 0383301000925
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 ANDA205096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (83301-0008-1)
  • 500 TABLET, COATED in 1 BOTTLE (83301-0008-2)
  • 1000 TABLET, COATED in 1 BOTTLE (83301-0008-3)
source: ndc

Packages (3)

83301-0008-1 100 TABLET, COATED in 1 BOTTLE (83301-0008-1) 83301-0008-2 500 TABLET, COATED in 1 BOTTLE (83301-0008-2) 83301-0008-3 1000 TABLET, COATED in 1 BOTTLE (83301-0008-3)

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": "423f5f82-8524-65aa-e063-6294a90a1180", "openfda": {"upc": ["0383301001014", "0383301000826", "0383301000925"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["082b4de9-e452-fe71-e063-6394a90ac863"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (83301-0008-1)", "package_ndc": "83301-0008-1", "marketing_start_date": "20240101"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (83301-0008-2)", "package_ndc": "83301-0008-2", "marketing_start_date": "20240101"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (83301-0008-3)", "package_ndc": "83301-0008-3", "marketing_start_date": "20240101"}], "brand_name": "Metformin Hydrochloride", "product_id": "83301-0008_423f5f82-8524-65aa-e063-6294a90a1180", "dosage_form": "TABLET, COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "83301-0008", "generic_name": "Metformin Hydrochloride", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA205096", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}