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 71610-554
Product ID 71610-554_91ab7bd9-ef80-437c-967b-3f11991c2139
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207427
Listing Expiration 2026-12-31
Marketing Start 2018-07-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610554
Hyphenated Format 71610-554

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 ANDA207427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-70)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-80)
  • 270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-92)
  • 360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-94)
source: ndc

Packages (7)

71610-554-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-30) 71610-554-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-53) 71610-554-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60) 71610-554-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-70) 71610-554-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-80) 71610-554-92 270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-92) 71610-554-94 360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-94)

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": "91ab7bd9-ef80-437c-967b-3f11991c2139", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["5e5fb10b-b874-43c9-9424-9080b9e866c8"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-30)", "package_ndc": "71610-554-30", "marketing_start_date": "20210512"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-53)", "package_ndc": "71610-554-53", "marketing_start_date": "20220131"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60)", "package_ndc": "71610-554-60", "marketing_start_date": "20210512"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-70)", "package_ndc": "71610-554-70", "marketing_start_date": "20210609"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-80)", "package_ndc": "71610-554-80", "marketing_start_date": "20220118"}, {"sample": false, "description": "270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-92)", "package_ndc": "71610-554-92", "marketing_start_date": "20210618"}, {"sample": false, "description": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-94)", "package_ndc": "71610-554-94", "marketing_start_date": "20210818"}], "brand_name": "Metformin hydrochloride", "product_id": "71610-554_91ab7bd9-ef80-437c-967b-3f11991c2139", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-554", "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": "ANDA207427", "marketing_category": "ANDA", "marketing_start_date": "20180717", "listing_expiration_date": "20261231"}