FDA.reportPublic FDA data

NDC 70518-4047-01 - 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
70518-4047
Requested NDC
70518-4047-01
Package NDCs from labels
70518-4047-0, 70518-4047-1, 70518-4047-2, 70518-4047-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NABUMETONE TABLETS USP Rx OnlyREMEDYREPACK INC.2026-02-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4047-0Nabumetone14 in 1 BOTTLE, PLASTICTABLET144
70518-4047-1Nabumetone60 in 1 BOTTLE, PLASTICTABLET604
70518-4047-2Nabumetone60 in 1 BOTTLE, PLASTICTABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4047NABUMETONE TABLET [REMEDYREPACK INC.]2Current NDC, 3 package rows20240517_6106afa3-e138-4b4d-8c13-992bf5062097.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 66 of 109 · 2,173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONEBryant Ranch Prepackad9f2a34-6244-49b7-98ee-af18cb55693c2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack06f73fa8-7a8f-4160-939e-a25980a119062025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack5a66c21f-4f06-4fb8-98fa-e81949586afd2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
NabumetoneNABUMETONEBryant Ranch Prepack419c597f-6a6f-4420-b240-7dc4c223387e2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepacka4553637-498e-491a-982a-cff81b43aa6c2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311893
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack5ba602e9-846e-42b3-9ea6-fb461a9489472025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONEBryant Ranch Prepack0be7ee60-2706-43ed-98ec-b89cd4e2b57c2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078420
rxcui: 311892
unii: LW0TIW155Z
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
unii: 15FIX9V2JP
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NabumetoneNABUMETONEExelan Pharmaceuticals Inc.16e76e29-9315-40c0-b1d6-8d91961063cf2025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
NabumetoneNABUMETONECipla USA Inc.85954380-a520-46d7-89ac-e4b19d6e00a12025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311893
rxcui: 311892
unii: LW0TIW155Z
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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