NDC 80425-0054-02 - 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
80425-0054
Requested NDC
80425-0054-02
Package NDCs from labels
80425-0054-1, 80425-0054-2, 80425-0054-02
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
80425-0054-1Nabumetone60 in 1 BOTTLETABLET606
80425-0054-2Nabumetone90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0054NABUMETONE TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_af9994ac-6687-2df2-e053-2995a90a959a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0054-1EA - Each80425-00545d8d5bfa-9e71-471d-b8a5-4ece884b351012023-06-06
80425-0054-2EA - Each80425-00542b04fc85-aa80-421e-b6c5-b5834462941112023-06-06

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 1 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONESportpharm LLC55e733f0-7633-4412-b5a3-07d9363bbd712026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEPreferred Pharmaceuticals, Inc.95769e02-fa4a-4389-a2fa-3146eae025262026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEPreferred Pharmaceuticals Inc.455c9992-39a0-4353-a121-57e700c779422026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEANI Pharmaceuticals, Inc.e87289f4-d4f9-4510-aaa5-51f8f81676582026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONESt. Mary's Medical Park Pharmacy95aa8124-08fe-ff2f-e053-2a95a90a3c8f2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEREMEDYREPACK INC.311ae656-55d2-4116-a1bd-6f4a4ce701852026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONESt. Mary's Medical Park Pharmacy94930125-b792-579e-e053-2995a90ab6f92026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEREMEDYREPACK INC.6106afa3-e138-4b4d-8c13-992bf50620972026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONENorthwind Health Company, LLCb088f564-43ff-8007-e053-2995a90ab0122026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONENorthwind Health Company, LLCd9ca2484-7293-7db6-e053-2995a90a0f132026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONENorthwind Health Company, LLCda34003b-81a4-2efd-e053-2995a90a961c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONERedpharm Drug3745775e-e11a-01db-e063-6294a90a9b522025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.75c51686-9c5e-4c13-acf4-2d04502eedda2025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEAmerican Health Packaging0653b873-b74b-4ec6-b112-675760703d912025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack0186328f-3eb7-4407-bf9e-8007d08ebe7b2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepackdd0d2652-d335-45db-af43-5a2523f7299a2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
Nabumetone 500 mgNABUMETONELGM PHARMA SOLUTIONS, LLCef7c3da8-797f-4ea9-8999-53509785a0f72025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEActavis Pharma, Inc.53656d70-6572-4669-6465-6c69735553412025-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.8f3c1b1d-2765-4cb5-92df-044b99339c922025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack583602ff-dbbe-4369-afa9-b917734ac9b12025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z

Reported adverse events (FAERS/openFDA)#

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