nabumetone

Generic: nabumetone

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nabumetone
Generic Name nabumetone
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nabumetone 500 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0053
Product ID 80425-0053_2a98d9c1-b76e-40b1-e063-6294a90a20e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078671
Listing Expiration 2026-12-31
Marketing Start 2019-03-06

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250053
Hyphenated Format 80425-0053

Supplemental Identifiers

RxCUI
311892
UNII
LW0TIW155Z
NUI
N0000000160 M0001335 N0000175722

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 nabumetone (source: ndc)
Generic Name nabumetone (source: ndc)
Application Number ANDA078671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0053-1)
source: ndc

Packages (1)

80425-0053-1 60 TABLET, FILM COATED in 1 BOTTLE (80425-0053-1)

Ingredients (1)

nabumetone (500 mg/1)

Linked Drug Pages (1)

Nabumetone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a98d9c1-b76e-40b1-e063-6294a90a20e4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["LW0TIW155Z"], "rxcui": ["311892"], "spl_set_id": ["af9969df-ce14-c0bc-e053-2995a90a3f59"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0053-1)", "package_ndc": "80425-0053-1", "marketing_start_date": "20190306"}], "brand_name": "Nabumetone", "product_id": "80425-0053_2a98d9c1-b76e-40b1-e063-6294a90a20e4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0053", "generic_name": "Nabumetone", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nabumetone", "active_ingredients": [{"name": "NABUMETONE", "strength": "500 mg/1"}], "application_number": "ANDA078671", "marketing_category": "ANDA", "marketing_start_date": "20190306", "listing_expiration_date": "20261231"}