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 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-917
Product ID 71610-917_388ee1e0-a0d3-324d-e063-6394a90a1664
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2026-12-31
Marketing Start 2015-02-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610917
Hyphenated Format 71610-917

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 hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-917-30)
  • 60 TABLET in 1 BOTTLE (71610-917-53)
  • 90 TABLET in 1 BOTTLE (71610-917-60)
  • 120 TABLET in 1 BOTTLE (71610-917-70)
  • 180 TABLET in 1 BOTTLE (71610-917-80)
  • 360 TABLET in 1 BOTTLE (71610-917-94)
source: ndc

Packages (6)

71610-917-30 30 TABLET in 1 BOTTLE (71610-917-30) 71610-917-53 60 TABLET in 1 BOTTLE (71610-917-53) 71610-917-60 90 TABLET in 1 BOTTLE (71610-917-60) 71610-917-70 120 TABLET in 1 BOTTLE (71610-917-70) 71610-917-80 180 TABLET in 1 BOTTLE (71610-917-80) 71610-917-94 360 TABLET in 1 BOTTLE (71610-917-94)

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": "388ee1e0-a0d3-324d-e063-6394a90a1664", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["388ee1e0-a0d2-324d-e063-6394a90a1664"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-917-30)", "package_ndc": "71610-917-30", "marketing_start_date": "20250626"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-917-53)", "package_ndc": "71610-917-53", "marketing_start_date": "20250626"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-917-60)", "package_ndc": "71610-917-60", "marketing_start_date": "20250626"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-917-70)", "package_ndc": "71610-917-70", "marketing_start_date": "20250626"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-917-80)", "package_ndc": "71610-917-80", "marketing_start_date": "20250626"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE (71610-917-94)", "package_ndc": "71610-917-94", "marketing_start_date": "20250626"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "71610-917_388ee1e0-a0d3-324d-e063-6394a90a1664", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-917", "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": "500 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20150201", "listing_expiration_date": "20261231"}