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 71610-578
Product ID 71610-578_ae39b6bc-4b1a-4db9-b5a1-7195832a1cec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206145
Listing Expiration 2026-12-31
Marketing Start 2018-10-27

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610578
Hyphenated Format 71610-578

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 ANDA206145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80)
  • 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94)
source: ndc

Packages (4)

71610-578-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60) 71610-578-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70) 71610-578-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80) 71610-578-94 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94)

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": "ae39b6bc-4b1a-4db9-b5a1-7195832a1cec", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["1e298db3-439e-4e91-8f9e-01c3cdc4d552"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60)", "package_ndc": "71610-578-60", "marketing_start_date": "20210701"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70)", "package_ndc": "71610-578-70", "marketing_start_date": "20210701"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80)", "package_ndc": "71610-578-80", "marketing_start_date": "20210701"}, {"sample": false, "description": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94)", "package_ndc": "71610-578-94", "marketing_start_date": "20210701"}], "brand_name": "Metformin Hydrochloride", "product_id": "71610-578_ae39b6bc-4b1a-4db9-b5a1-7195832a1cec", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-578", "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": "ANDA206145", "marketing_category": "ANDA", "marketing_start_date": "20181027", "listing_expiration_date": "20261231"}