FDA.reportPublic FDA data

NDC 70518-1802-2 - Duloxetine Delayed-Release

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
70518-1802
Requested NDC
70518-1802-2
Package NDCs from labels
70518-1802-0, 70518-1802-2, 70518-1802-1, 70518-1802-3
Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Duloxetine Delayed-Release - REMEDYREPACK INC.REMEDYREPACK INC.2022-03-14HUMAN PRESCRIPTION DRUG LABEL

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 71 of 118 · 2,354 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEPreferred Pharmaceuticals Inc.71256b03-867f-4c5e-aa5d-75d1bb705fcb2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEPreferred Pharmaceuticals, Inc.7a7c67be-6800-4ec3-9072-1e0e390a854b2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEAsclemed USA, Inc.f61bd9f3-cd3d-4c76-a110-0f1dcba610af2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 616402
rxcui: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackf66f63c8-51db-4183-a452-78205cf3a2632025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 616402
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack276ca221-354c-484d-93d5-0698cb2cfd562025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596930
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka23e79b3-7bd3-4b83-beb0-dc23d4830e9e2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka5804a0b-ceae-4ebd-bba0-bfc10e21b90d2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596926
unii: 9044SC542W
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
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka891f20f-83ff-4960-81ef-9e74d01a452e2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596926
unii: 9044SC542W
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackc934cc41-b40b-4c5c-b019-a749eec52d882025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 616402
unii: 9044SC542W
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
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackca36f94c-2215-436f-ada8-7319f4f3e0542025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596930
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackb25c01e0-273a-4f8f-a37e-9b17e5cf378f2025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596926
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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