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 71610-837
Product ID 71610-837_1a0499c1-6f4c-d51b-e063-6294a90a72fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201991
Listing Expiration 2026-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610837
Hyphenated Format 71610-837

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 ANDA201991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-70)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-80)
  • 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-94)
source: ndc

Packages (6)

71610-837-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-30) 71610-837-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-53) 71610-837-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-60) 71610-837-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-70) 71610-837-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-80) 71610-837-94 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-94)

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": "1a0499c1-6f4c-d51b-e063-6294a90a72fb", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["1a047fc0-196e-79af-e063-6394a90a1e0d"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-30)", "package_ndc": "71610-837-30", "marketing_start_date": "20240531"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-53)", "package_ndc": "71610-837-53", "marketing_start_date": "20240531"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-60)", "package_ndc": "71610-837-60", "marketing_start_date": "20240531"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-70)", "package_ndc": "71610-837-70", "marketing_start_date": "20240531"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-80)", "package_ndc": "71610-837-80", "marketing_start_date": "20240531"}, {"sample": false, "description": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-94)", "package_ndc": "71610-837-94", "marketing_start_date": "20240531"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "71610-837_1a0499c1-6f4c-d51b-e063-6294a90a72fb", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-837", "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": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}