metformin hydrochloride

Generic: metformin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-923
Product ID 71610-923_3982d64b-ad92-ae75-e063-6294a90aa936
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2026-12-31
Marketing Start 2013-09-11

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610923
Hyphenated Format 71610-923

Supplemental Identifiers

RxCUI
861010
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 ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-923-30)
  • 60 TABLET in 1 BOTTLE (71610-923-53)
  • 90 TABLET in 1 BOTTLE (71610-923-60)
  • 180 TABLET in 1 BOTTLE (71610-923-80)
  • 270 TABLET in 1 BOTTLE (71610-923-92)
source: ndc

Packages (5)

71610-923-30 30 TABLET in 1 BOTTLE (71610-923-30) 71610-923-53 60 TABLET in 1 BOTTLE (71610-923-53) 71610-923-60 90 TABLET in 1 BOTTLE (71610-923-60) 71610-923-80 180 TABLET in 1 BOTTLE (71610-923-80) 71610-923-92 270 TABLET in 1 BOTTLE (71610-923-92)

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": "3982d64b-ad92-ae75-e063-6294a90aa936", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861010"], "spl_set_id": ["3982b985-9184-0e17-e063-6394a90aae05"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-923-30)", "package_ndc": "71610-923-30", "marketing_start_date": "20250708"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-923-53)", "package_ndc": "71610-923-53", "marketing_start_date": "20250708"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-923-60)", "package_ndc": "71610-923-60", "marketing_start_date": "20250708"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-923-80)", "package_ndc": "71610-923-80", "marketing_start_date": "20250708"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-923-92)", "package_ndc": "71610-923-92", "marketing_start_date": "20250708"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "71610-923_3982d64b-ad92-ae75-e063-6294a90aa936", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-923", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20130911", "listing_expiration_date": "20261231"}