FDA.reportPublic FDA data

NDC 70518-4313-01 - Atomoxetine Hydrochloride

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
70518-4313
Requested NDC
70518-4313-01
Package NDCs from labels
70518-4313-1, 70518-4313-0, 70518-4313-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atomoxetine Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4313-0Atomoxetine Hydrochloride30 in 1 BOXCAPSULE303
70518-4313-1Atomoxetine Hydrochloride1 in 1 POUCHCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4313ATOMOXETINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]1Current NDC, 2 package rows20250322_6d7ea8f7-981c-4acc-aeaf-7516325bfc0c.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 54 of 102 · 2,031 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 SandalwoodOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2765f345-eab2-4878-b1f1-f8e2430834762025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 ToffeeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASd1181543-07ab-4a51-8b55-afc1a98293f62025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc7be3a7e-f031-4ec0-b9dc-41c025cd00662025-10-22WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC41c0c262-21c3-b8e6-e063-6394a90a7c9c2025-10-22WarningsExact identifier
unii: 15FIX9V2JP
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENKRX RESOURCES SDN. BHD.22b8856b-671f-def3-e063-6394a90a4ea02025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted Sunscreen Medium DarkCLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARKKRX RESOURCES SDN. BHD.22cead37-f862-e859-e063-6394a90a86ce2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERKRX RESOURCES SDN. BHD.22a60fb9-0fea-92c0-e063-6394a90a088c2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
AtomoxetineATOMOXETINEBryant Ranch Prepackbb2c12e4-563c-417e-bee1-6d8c51e75af42025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349593
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEBryant Ranch Prepackc5e9e305-8d99-4234-b531-6ade177768b72025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349594
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEBryant Ranch Prepack1d26aff3-72a7-4a5b-a6fe-44dc8a08b1962025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349595
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEBryant Ranch Prepack9c1f858c-8721-49e3-be8b-bf180e89ff422025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349592
unii: 57WVB6I2W0
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
AtomoxetineATOMOXETINEBryant Ranch Prepackbbb2a8f6-0816-47b1-830a-ef23e97d498f2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 608143
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEBryant Ranch Prepackc6542d69-d0a2-4663-9172-943f9f6f53252025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 608139
unii: 57WVB6I2W0
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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