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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8289
Product ID 0615-8289_e3d84126-2927-4507-aaef-6fc37fc5b105
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 06158289
Hyphenated Format 0615-8289

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
  • 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-28)
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-39)
source: ndc

Packages (2)

0615-8289-28 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-28) 0615-8289-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-39)

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": "e3d84126-2927-4507-aaef-6fc37fc5b105", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["5bb945c1-954a-4d43-aa24-33767d19c57c"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-28)", "package_ndc": "0615-8289-28", "marketing_start_date": "20240328"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-39)", "package_ndc": "0615-8289-39", "marketing_start_date": "20190610"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "0615-8289_e3d84126-2927-4507-aaef-6fc37fc5b105", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0615-8289", "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": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}