metformin hydrochloride extended release

Generic: metformin hydrochloride

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride extended release
Generic Name metformin hydrochloride
Labeler direct rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
direct rx

Identifiers & Regulatory

Product NDC 72189-064
Product ID 72189-064_2c4ea7fa-b789-8bdf-e063-6394a90a3e5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090295
Listing Expiration 2026-12-31
Marketing Start 2020-06-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189064
Hyphenated Format 72189-064

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 extended release (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA090295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-90)
source: ndc

Packages (2)

72189-064-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-30) 72189-064-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-90)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE EXTENDED RELEASE, METFORMIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4ea7fa-b789-8bdf-e063-6394a90a3e5a", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["a84cf1a3-3820-cd1b-e053-2995a90acf45"], "manufacturer_name": ["direct rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-30)", "package_ndc": "72189-064-30", "marketing_start_date": "20200617"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-90)", "package_ndc": "72189-064-90", "marketing_start_date": "20200617"}], "brand_name": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "product_id": "72189-064_2c4ea7fa-b789-8bdf-e063-6394a90a3e5a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "72189-064", "generic_name": "metformin hydrochloride", "labeler_name": "direct rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090295", "marketing_category": "ANDA", "marketing_start_date": "20200617", "listing_expiration_date": "20261231"}