FDA.reportPublic FDA data

NDC 79739-7076-01 - Nabumetone 500 mg

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
79739-7076
Requested NDC
79739-7076-01
Package NDCs from labels
79739-7076-1, 79739-7076-5, 79739-7076-01
Manufacturer
LGM PHARMA SOLUTIONS, LLC
Effective date
2025-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nabumetone 500 mg - LGM PHARMA SOLUTIONS, LLCLGM PHARMA SOLUTIONS, LLC2025-08-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79739-7076-1Nabumetone 500 mg100 in 1 BOTTLETABLET, FILM COATED1004
79739-7076-5Nabumetone 500 mg500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79739-7076NABUMETONE 500 MG (NABUMETONE) TABLET, FILM COATED NABUMETONE 750 MG (NABUMETONE) TABLET, FILM COATED NABUMETONE 1000 MG (NABUMETONE) TABLET, FILM COATED [LGM PHARMA SOLUTIONS, LLC]3Current NDC, Legacy NDC, 2 package rows20240123_ef7c3da8-797f-4ea9-8999-53509785a0f7.zip

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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
NabumetoneNABUMETONERedpharm Drug3745775e-e11a-01db-e063-6294a90a9b522025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.75c51686-9c5e-4c13-acf4-2d04502eedda2025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEAmerican Health Packaging0653b873-b74b-4ec6-b112-675760703d912025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311892
unii: LW0TIW155Z
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
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
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Nabumetone 500 mgNABUMETONELGM PHARMA SOLUTIONS, LLCef7c3da8-797f-4ea9-8999-53509785a0f72025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203166
ndc (package): 79739-7077-5
ndc (package): 79739-7078-1
ndc (package): 79739-7078-3
ndc (package): 79739-7078-6
ndc (package): 79739-7077-1
ndc (package): 79739-7076-1
ndc (package): 79739-7076-5
ndc (product): 79739-7077
ndc (product): 79739-7076
ndc (product): 79739-7078
ndc11 (package): 79739707601
rxcui: 311893
rxcui: 427726
rxcui: 311892
spl id: cf52d275-4853-4576-832a-07630bb644dc
spl set id: ef7c3da8-797f-4ea9-8999-53509785a0f7
unii: LW0TIW155Z
NabumetoneNABUMETONEActavis Pharma, Inc.53656d70-6572-4669-6465-6c69735553412025-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z

Reported adverse events (FAERS/openFDA)#

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