metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

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

metformin hydrochloride 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-195
Product ID 82804-195_7cb47c3e-6657-4c11-8aa2-ae172e5a8529
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078321
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804195
Hyphenated Format 82804-195

Supplemental Identifiers

RxCUI
860975
UPC
0382804195602
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 ANDA078321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-195-60)
source: ndc

Packages (1)

82804-195-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-195-60)

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": "7cb47c3e-6657-4c11-8aa2-ae172e5a8529", "openfda": {"upc": ["0382804195602"], "unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["7cb47c3e-6657-4c11-8aa2-ae172e5a8529"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-195-60)", "package_ndc": "82804-195-60", "marketing_start_date": "20250210"}], "brand_name": "Metformin Hydrochloride", "product_id": "82804-195_7cb47c3e-6657-4c11-8aa2-ae172e5a8529", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "82804-195", "generic_name": "Metformin Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078321", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}