metformin

Generic: metformin er 500 mg

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

Drug Facts

Product Profile

Brand Name metformin
Generic Name metformin er 500 mg
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 71610-613
Product ID 71610-613_1a8b9788-48c5-15f5-e063-6394a90a2e11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209313
Listing Expiration 2026-12-31
Marketing Start 2018-07-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610613
Hyphenated Format 71610-613

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 (source: ndc)
Generic Name metformin er 500 mg (source: ndc)
Application Number ANDA209313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-613-30)
  • 60 TABLET in 1 BOTTLE (71610-613-53)
  • 90 TABLET in 1 BOTTLE (71610-613-60)
  • 120 TABLET in 1 BOTTLE (71610-613-70)
  • 180 TABLET in 1 BOTTLE (71610-613-80)
  • 360 TABLET in 1 BOTTLE (71610-613-94)
source: ndc

Packages (6)

71610-613-30 30 TABLET in 1 BOTTLE (71610-613-30) 71610-613-53 60 TABLET in 1 BOTTLE (71610-613-53) 71610-613-60 90 TABLET in 1 BOTTLE (71610-613-60) 71610-613-70 120 TABLET in 1 BOTTLE (71610-613-70) 71610-613-80 180 TABLET in 1 BOTTLE (71610-613-80) 71610-613-94 360 TABLET in 1 BOTTLE (71610-613-94)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a8b9788-48c5-15f5-e063-6394a90a2e11", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-613-30)", "package_ndc": "71610-613-30", "marketing_start_date": "20240502"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-613-53)", "package_ndc": "71610-613-53", "marketing_start_date": "20240604"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-613-60)", "package_ndc": "71610-613-60", "marketing_start_date": "20211102"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-613-70)", "package_ndc": "71610-613-70", "marketing_start_date": "20240301"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-613-80)", "package_ndc": "71610-613-80", "marketing_start_date": "20211102"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE (71610-613-94)", "package_ndc": "71610-613-94", "marketing_start_date": "20211102"}], "brand_name": "Metformin", "product_id": "71610-613_1a8b9788-48c5-15f5-e063-6394a90a2e11", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-613", "generic_name": "Metformin ER 500 mg", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209313", "marketing_category": "ANDA", "marketing_start_date": "20180731", "listing_expiration_date": "20261231"}