FDA.reportPublic FDA data

NDC 85534-0052-01 - 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
85534-0052
Requested NDC
85534-0052-01
Package NDCs from labels
85534-0052-0, 85534-0052-1, 85534-0052-2, 85534-0052-3, 85534-0052-01
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, INC.HAWAII REPACK, INC.2026-09-09HUMAN 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 21 of 296 · 5,905 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEREMEDYREPACK INC.b149641a-03e6-4fee-91f3-7ba8e01196bd2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596930
unii: 9044SC542W
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
American Red Cross IPA 50% 6ozAMERICAN RED CROSS IPA 50% 6OZTSM BRANDS LLC29195bac-b096-ab8d-e063-6394a90a424a2026-07-01WarningsExact identifier
unii: ND2M416302
American Red Cross 6oz, 50% Isopropyl AlcoholAMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAYMY IMPORTS USA LLC2929d580-cfff-e2b6-e063-6394a90a79aa2026-07-01WarningsExact identifier
unii: ND2M416302
Medi Fect Antiseptic Hand WashETHYL ALCOHOLMedical Chemical Corporationdc397d9c-9c12-41e5-ab7f-196fcad5bf972026-07-01WarningsExact identifier
unii: 3K9958V90M
AloeSafe Antiseptic Hand SanitizerETHYL ALCOHOLMedical Chemical Corporation950f012e-7908-523c-e053-2995a90afa6b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Berry BlissALCOHOLBath & Body Works, Inc.55935d41-ce7a-796a-e063-6294a90a6ba22026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Tangerine TwirlALCOHOLBath & Body Works, Inc.55933da8-dfbc-6877-e063-6394a90abb7f2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Watermelon WhirlALCOHOLBath & Body Works, Inc.559364cc-2b55-9628-e063-6394a90ac8e62026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach SandalwoodETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55984504-188f-13bc-e063-6394a90a91502026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ed5f-ed98-ebeb-e063-6294a90a2e8d2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry CremeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598c831-3986-00a5-e063-6394a90a1e662026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55982f73-7baa-26a7-e063-6394a90ab74b2026-07-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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