metformin hydrochloride extended release

Generic: metformin hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metformin hydrochloride 750 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-148
Product ID 82804-148_0e1e77e6-1d37-4d24-b70d-dc2bad97b46c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090295
Listing Expiration 2026-12-31
Marketing Start 2016-05-12

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804148
Hyphenated Format 82804-148

Supplemental Identifiers

RxCUI
860981
UPC
0382804148004
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
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-00)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-30)
source: ndc

Packages (2)

82804-148-00 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-00) 82804-148-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-30)

Ingredients (1)

metformin hydrochloride (750 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e1e77e6-1d37-4d24-b70d-dc2bad97b46c", "openfda": {"upc": ["0382804148004"], "unii": ["786Z46389E"], "rxcui": ["860981"], "spl_set_id": ["f1530d4f-21d9-4a4f-a814-07b180828ecd"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-00)", "package_ndc": "82804-148-00", "marketing_start_date": "20240920"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-30)", "package_ndc": "82804-148-30", "marketing_start_date": "20250220"}], "brand_name": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "product_id": "82804-148_0e1e77e6-1d37-4d24-b70d-dc2bad97b46c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "82804-148", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA090295", "marketing_category": "ANDA", "marketing_start_date": "20160512", "listing_expiration_date": "20261231"}