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 2 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONEBryant Ranch Prepackb2a41c0b-e2ad-4e14-a2f7-2049c12c35da2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepackad9f2a34-6244-49b7-98ee-af18cb55693c2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack06f73fa8-7a8f-4160-939e-a25980a119062025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack5a66c21f-4f06-4fb8-98fa-e81949586afd2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack419c597f-6a6f-4420-b240-7dc4c223387e2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepacka4553637-498e-491a-982a-cff81b43aa6c2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack5ba602e9-846e-42b3-9ea6-fb461a9489472025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack0be7ee60-2706-43ed-98ec-b89cd4e2b57c2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEExelan Pharmaceuticals Inc.16e76e29-9315-40c0-b1d6-8d91961063cf2025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078671
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONECipla USA Inc.85954380-a520-46d7-89ac-e4b19d6e00a12025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078671
ndc (product): 69097-965
rxcui: 311893
rxcui: 311892
spl id: 46daea72-1c6d-41ce-b8d0-c412ca0d908e
spl set id: 85954380-a520-46d7-89ac-e4b19d6e00a1
unii: LW0TIW155Z
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.69620c53-b37a-45b9-b560-221bbcd98fda2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NABUMETONENABUMETONEdirect rxa8600b12-f180-0b27-e053-2995a90acbd92025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEScieGen Pharmaceuticals Inc80c6888d-03b4-44f3-b94d-bcf5154ceae52025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEAdvanced Rx of Tennessee, LLCaf9969df-ce14-c0bc-e053-2995a90a3f592024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078671
ndc (package): 80425-0053-1
ndc (product): 80425-0053
ndc11 (package): 80425005301
rxcui: 311892
spl id: 2a98d9c1-b76e-40b1-e063-6294a90a20e4
spl set id: af9969df-ce14-c0bc-e053-2995a90a3f59
unii: LW0TIW155Z
NabumetoneNABUMETONEAdvanced Rx of Tennessee, LLCaf9994ac-6687-2df2-e053-2995a90a959a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEAdvanced Rx Pharmacy of Tennessee, LLCb43db4aa-6013-3942-e053-2a95a90a51892024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEQuality Care Products, LLCda259c7c-6f1e-403c-b42b-596d53b61fe52024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEQuality Care Products, LLC065fdacc-739e-4b46-bebc-044b5c11bbbb2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEA-S Medication Solutions26037234-daca-4f1a-a7a7-0871f77283f02024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEA-S Medication Solutionsd997d125-dfc5-4cc5-b7a6-03f5a7248d142024-10-25Boxed 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.