metformin hydrochloride

Generic: metformin hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8015
Product ID 0615-8015_18821d8d-d7d6-4697-8b14-030a1c69cb73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077095
Marketing Start 2005-01-14
Marketing End 2027-01-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158015
Hyphenated Format 0615-8015

Supplemental Identifiers

RxCUI
861004 861007 861010
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 ANDA077095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-05)
  • 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-28)
  • 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8015-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-39)
source: ndc

Packages (4)

0615-8015-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-05) 0615-8015-28 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-28) 0615-8015-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8015-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK 0615-8015-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-39)

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": "18821d8d-d7d6-4697-8b14-030a1c69cb73", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["23aa0072-365c-4d13-9aa7-ae23f7e00ee4"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-05)", "package_ndc": "0615-8015-05", "marketing_end_date": "20270131", "marketing_start_date": "20050114"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-28)", "package_ndc": "0615-8015-28", "marketing_end_date": "20270131", "marketing_start_date": "20240423"}, {"sample": false, "description": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8015-30)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0615-8015-30", "marketing_end_date": "20270131", "marketing_start_date": "20190424"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-39)", "package_ndc": "0615-8015-39", "marketing_end_date": "20270131", "marketing_start_date": "20050114"}], "brand_name": "Metformin Hydrochloride", "product_id": "0615-8015_18821d8d-d7d6-4697-8b14-030a1c69cb73", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0615-8015", "generic_name": "Metformin Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077095", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20050114"}