metformin hydrochloride er

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

metformin hydrochloride 750 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-867
Product ID 71610-867_2bc26279-774d-c799-e063-6394a90aae86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207427
Listing Expiration 2026-12-31
Marketing Start 2024-06-11

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610867
Hyphenated Format 71610-867

Supplemental Identifiers

RxCUI
860981
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 er (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA207427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80)
source: ndc

Packages (4)

71610-867-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53) 71610-867-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60) 71610-867-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70) 71610-867-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80)

Ingredients (1)

metformin hydrochloride (750 mg/1)

Linked Drug Pages (1)

Metformin hydrochloride ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bc26279-774d-c799-e063-6394a90aae86", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860981"], "spl_set_id": ["27d6fdbc-27a8-c599-e063-6394a90a2233"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53)", "package_ndc": "71610-867-53", "marketing_start_date": "20241125"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60)", "package_ndc": "71610-867-60", "marketing_start_date": "20241125"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70)", "package_ndc": "71610-867-70", "marketing_start_date": "20241125"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80)", "package_ndc": "71610-867-80", "marketing_start_date": "20250113"}], "brand_name": "Metformin hydrochloride ER", "product_id": "71610-867_2bc26279-774d-c799-e063-6394a90aae86", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-867", "generic_name": "Metformin hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "brand_name_suffix": "ER", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA207427", "marketing_category": "ANDA", "marketing_start_date": "20240611", "listing_expiration_date": "20261231"}