metformin er 500 mg

Generic: metformin er 500 mg

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin er 500 mg
Generic Name metformin er 500 mg
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-117
Product ID 82009-117_451e9a75-128c-6b1d-e063-6394a90aa5d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209313
Listing Expiration 2026-12-31
Marketing Start 2023-07-25

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009117
Hyphenated Format 82009-117

Supplemental Identifiers

RxCUI
860975 860981
UPC
0382009117102 0382009118017
UNII
786Z46389E

Packaging Origin

Original Packager
true

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 er 500 mg (source: ndc)
Generic Name metformin er 500 mg (source: ndc)
Application Number ANDA209313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (82009-117-10)
source: ndc

Packages (1)

82009-117-10 1000 TABLET in 1 BOTTLE (82009-117-10)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin ER 500 mg, Metformin ER 750 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451e9a75-128c-6b1d-e063-6394a90aa5d8", "openfda": {"upc": ["0382009117102", "0382009118017"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["ff196435-14f4-8b9d-e053-6294a90a4ee8"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (82009-117-10)", "package_ndc": "82009-117-10", "marketing_start_date": "20230725"}], "brand_name": "Metformin ER 500 mg", "product_id": "82009-117_451e9a75-128c-6b1d-e063-6394a90aa5d8", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "82009-117", "generic_name": "Metformin ER 500 mg", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin ER 500 mg", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209313", "marketing_category": "ANDA", "marketing_start_date": "20230725", "listing_expiration_date": "20261231"}