FDA.reportPublic FDA data

NDC 70518-4337-01 - Atomoxetine

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
70518-4337
Requested NDC
70518-4337-01
Package NDCs from labels
70518-4337-1, 70518-4337-0, 70518-4337-01
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 - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4337-0Atomoxetine30 in 1 BOXCAPSULE302
70518-4337-1Atomoxetine1 in 1 POUCHCAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4337ATOMOXETINE CAPSULE [REMEDYREPACK INC.]1Current NDC, 2 package rows20250522_d7002d75-edad-4141-91bf-7eebf50ad1aa.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 43 of 315 · 6,288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios Inc.80e475a5-97d7-4ad9-9be1-0ccdb42e6fce2026-05-12WarningsExact identifier
unii: 3K9958V90M
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Firstcare Gas Relief Simethicone 250 mg Anti-gasSIMETHICONE 250 MGUSpharma Ltd9625a697-fadc-483b-b83a-fa2cc76002ba2026-05-12WarningsExact identifier
unii: 92RU3N3Y1O
Firstcare Gas Relief Simethicone 125 mg Anti-gasSIMETHICONE 125 MGUSpharma Ltde92c9661-01f2-42be-af54-42e60efcae352026-05-12WarningsExact identifier
unii: 92RU3N3Y1O
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.408ba9aa-6e03-48fe-a08e-799dbaa3408c2026-05-12WarningsExact identifier
unii: 3K9958V90M
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Smart Care ROSEWATER HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0a5a21d9-6832-47a2-a4bb-83781aaa61aa2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care LILY WATER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.898829cb-23e0-431b-be67-246c245b3dd52026-05-12WarningsExact identifier
unii: 3K9958V90M
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
atomoxetineATOMOXETINEA-S Medication Solutions90f45a1e-f79f-468f-b21b-5dc82f5717aa2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 608139
unii: 57WVB6I2W0
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERETHYL ALCOHOLLESSDOTW CO.,LTD.518657d5-9ee6-f8ca-e063-6294a90af5952026-05-11WarningsExact identifier
unii: 3K9958V90M
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
Beverly Gel Hand SanitizerETHYL ALCOHOLCleanslate Group LLC0e999251-cb51-ceec-e063-6294a90a35ad2026-05-11WarningsExact identifier
unii: 3K9958V90M
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
SANAR DECOLORIZED IODINEETHYL ALCOHOLEVI LABS518d399a-009e-c54f-e063-6294a90ab8382026-05-11WarningsExact identifier
unii: 3K9958V90M
Amora Hand Sanitizer WatermelonALCOHOLI World LLC45f9b0a2-972f-4d44-aad1-8999313d41912026-05-11WarningsExact identifier
unii: 3K9958V90M
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Amora Hand Sanitizer CherryALCOHOLI World LLCd9445e2a-e7f0-41ab-9b89-17cdf9fd7d5f2026-05-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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