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 1000 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8578
Product ID 0615-8578_27ec7057-a880-4145-a136-0dfb836ebc7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077095
Listing Expiration 2026-12-31
Marketing Start 2024-03-29

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158578
Hyphenated Format 0615-8578

Supplemental Identifiers

RxCUI
861004 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
  • 1000 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-39)
source: ndc

Packages (2)

0615-8578-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-05) 0615-8578-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-39)

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": "27ec7057-a880-4145-a136-0dfb836ebc7d", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861010"], "spl_set_id": ["0448c618-2f0d-4ed3-866f-74b413cf902d"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-05)", "package_ndc": "0615-8578-05", "marketing_start_date": "20250417"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-39)", "package_ndc": "0615-8578-39", "marketing_start_date": "20250417"}], "brand_name": "Metformin Hydrochloride", "product_id": "0615-8578_27ec7057-a880-4145-a136-0dfb836ebc7d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0615-8578", "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": "1000 mg/1"}], "application_number": "ANDA077095", "marketing_category": "ANDA", "marketing_start_date": "20240329", "listing_expiration_date": "20261231"}