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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-533
Product ID 71610-533_61eefdc5-924c-4798-a8fd-ed8155dd85c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078321
Listing Expiration 2026-12-31
Marketing Start 2008-04-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610533
Hyphenated Format 71610-533

Supplemental Identifiers

RxCUI
860975
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 ANDA078321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-70)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-80)
source: ndc

Packages (5)

71610-533-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-30) 71610-533-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-53) 71610-533-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-60) 71610-533-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-70) 71610-533-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-80)

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": "61eefdc5-924c-4798-a8fd-ed8155dd85c0", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["4d89a4ab-6cdd-4c39-92f9-a137fa27a070"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-30)", "package_ndc": "71610-533-30", "marketing_start_date": "20210415"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-53)", "package_ndc": "71610-533-53", "marketing_start_date": "20210309"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-60)", "package_ndc": "71610-533-60", "marketing_start_date": "20210415"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-70)", "package_ndc": "71610-533-70", "marketing_start_date": "20210518"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-80)", "package_ndc": "71610-533-80", "marketing_start_date": "20210518"}], "brand_name": "Metformin Hydrochloride", "product_id": "71610-533_61eefdc5-924c-4798-a8fd-ed8155dd85c0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-533", "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": "ANDA078321", "marketing_category": "ANDA", "marketing_start_date": "20080417", "listing_expiration_date": "20261231"}