FDA.reportPublic FDA data

NDC 80425-0053-01 - Nabumetone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0053
Requested NDC
80425-0053-01
Package NDCs from labels
80425-0053-1, 80425-0053-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nabumetone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0053-1Nabumetone60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0053NABUMETONE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_af9969df-ce14-c0bc-e053-2995a90a3f59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0053-1EA - Each80425-0053a4e8ad19-70dc-4c47-9cf5-d9df2892889a12023-06-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONEWestminster Pharmaceuticals, LLC264df44a-e294-4d9b-9113-92859cb08c202024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack62f2e0bf-e5c8-480c-ac5e-401ced3bbc672024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
RELAFEN DSNABUMETONECarwin Pharmaceutical Associates, LLCa9a0af85-6c43-4a2d-ba75-0be4ca64c9312024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: LW0TIW155Z
NabumetoneNABUMETONELupin Pharmaceuticals, Inc.cf96d189-5417-4181-a5fb-169b269560a22023-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEChartwell RX, LLC84bb2887-bab4-46ae-a07c-fa2a32c04b502023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEProficient Rx LP0870c3c9-bfce-4722-8779-8775644196d32022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEProficient Rx LP7a1643bf-6627-4b12-8246-6acc40517cf22022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEProficient Rx LPf4392863-ed3f-4fbd-8260-49827609aa2e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEAsclemed USA, Inc.04a71deb-2c9d-436c-a574-e5991b6a52482022-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEProficient Rx LP079a8a9e-6d71-414a-83f3-ef68e323c1fd2020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.