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 1000 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-673
Product ID 71610-673_2e3c04ee-8af6-4b53-88eb-833fdb555094
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610673
Hyphenated Format 71610-673

Supplemental Identifiers

RxCUI
861004
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-673-30)
  • 45 TABLET in 1 BOTTLE (71610-673-45)
  • 60 TABLET in 1 BOTTLE (71610-673-53)
  • 90 TABLET in 1 BOTTLE (71610-673-60)
  • 120 TABLET in 1 BOTTLE (71610-673-70)
  • 180 TABLET in 1 BOTTLE (71610-673-80)
source: ndc

Packages (6)

71610-673-30 30 TABLET in 1 BOTTLE (71610-673-30) 71610-673-45 45 TABLET in 1 BOTTLE (71610-673-45) 71610-673-53 60 TABLET in 1 BOTTLE (71610-673-53) 71610-673-60 90 TABLET in 1 BOTTLE (71610-673-60) 71610-673-70 120 TABLET in 1 BOTTLE (71610-673-70) 71610-673-80 180 TABLET in 1 BOTTLE (71610-673-80)

Ingredients (1)

metformin hydrochloride (1000 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": "2e3c04ee-8af6-4b53-88eb-833fdb555094", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-673-30)", "package_ndc": "71610-673-30", "marketing_start_date": "20221103"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-673-45)", "package_ndc": "71610-673-45", "marketing_start_date": "20221103"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-673-53)", "package_ndc": "71610-673-53", "marketing_start_date": "20221103"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-673-60)", "package_ndc": "71610-673-60", "marketing_start_date": "20221103"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-673-70)", "package_ndc": "71610-673-70", "marketing_start_date": "20221103"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-673-80)", "package_ndc": "71610-673-80", "marketing_start_date": "20221103"}], "brand_name": "Metformin Hydrochloride", "product_id": "71610-673_2e3c04ee-8af6-4b53-88eb-833fdb555094", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-673", "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": "1000 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}