NDC 85534-0050-01 - Duloxetine

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
85534-0050
Requested NDC
85534-0050-01
Package NDCs from labels
85534-0050-0, 85534-0050-1, 85534-0050-2, 85534-0050-3, 85534-0050-01
Manufacturer
HAWAII REPACK, INC
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Duloxetine - HAWAII REPACK, INCHAWAII REPACK, INC2026-09-09HUMAN 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 68 of 115 · 2,282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KARYNG Complete SPF Sunscreen Light/MediumSUNSCREENKaryng LLC33596253-413d-fba3-e063-6394a90a39e42025-04-22WarningsExact identifier
unii: 15FIX9V2JP
KARYNG Complete SPF Sunscreen Medium/DarkSUNSCREENKaryng LLC335eee1e-ef1c-41da-e063-6294a90ac2732025-04-22WarningsExact identifier
unii: 15FIX9V2JP
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
unii: 15FIX9V2JP
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
unii: 15FIX9V2JP
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
unii: 15FIX9V2JP
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.2c233b3f-83de-40c4-9f1d-81f901f894592025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
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: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackf66f63c8-51db-4183-a452-78205cf3a2632025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack276ca221-354c-484d-93d5-0698cb2cfd562025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka23e79b3-7bd3-4b83-beb0-dc23d4830e9e2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka5804a0b-ceae-4ebd-bba0-bfc10e21b90d2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
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
rxcui: 596926
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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