FDA.reportPublic FDA data

NDC 70518-0122-4 - 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
70518-0122
Requested NDC
70518-0122-4
Package NDCs from labels
70518-0122-0, 70518-0122-1, 70518-0122-2, 70518-0122-4, 70518-0122-3, 70518-0122-5
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-23
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.2026-06-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0122-0DuloxetineDelayed-Release30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS3014
70518-0122-1DuloxetineDelayed-Release30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS3014
70518-0122-2DuloxetineDelayed-Release60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS6014
70518-0122-3DuloxetineDelayed-Release100 in 1 BOXCAPSULE, DELAYED RELEASE PELLETS10014
70518-0122-4DuloxetineDelayed-Release1 in 1 POUCHCAPSULE, DELAYED RELEASE PELLETS114
70518-0122-5DuloxetineDelayed-Release90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0122DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 6 package rows20250529_b9f20917-9529-4c62-bafe-baae7f8d6c77.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 15 of 117 · 2,324 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEAlmatica Pharma LLCbb2ca3bf-983c-1e4a-a91d-dc7dee66d7412026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
DuloxetineDULOXETINEActavis Pharma, Inc.9dab9154-b86f-40dc-a4d1-18e6534dbc782026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
DuloxetineDULOXETINEA-S Medication Solutions3424a326-9543-44f7-b31c-f84e125092382026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutionscdd870a9-3bed-42fc-b175-48aed53219692026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
Duloxetine D/RDULOXETINE D/RDirect_Rx4a66fde2-4cce-b92e-e063-6294a90a63ee2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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