FDA.reportPublic FDA data

NDC 60505-2831-03 - 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
60505-2831
Requested NDC
60505-2831-03
Package NDCs from labels
60505-2831-3, 60505-2831-1, 60505-2831-8, 60505-2831-0, 60505-2831-03
Manufacturer
Apotex Corp.
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atomoxetine Hydrochloride - Apotex Corp.Apotex Corp.2026-08-11HUMAN PRESCRIPTION DRUG LABEL
Atomoxetine Hydrochloride - Golden State Medical Supply, Inc.Golden State Medical Supply, Inc.2025-05-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2831-0Atomoxetine Hydrochloride10 in 1 CARTONCAPSULE1020
60505-2831-0Atomoxetine Hydrochloride10 in 1 BLISTER PACKCAPSULE1020
60505-2831-1Atomoxetine Hydrochloride100 in 1 BOTTLECAPSULE10020
60505-2831-3Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE3020
60505-2831-8Atomoxetine Hydrochloride1000 in 1 BOTTLECAPSULE100020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2831ATOMOXETINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]20Current NDC, Legacy NDC, 5 package rows20250412_132852a6-5bff-15dd-255c-98309dd83630.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2831-3EA - Each60505-2831e70d01c8-2a74-47d2-ab36-ea0fd5b64a9e12018-06-11

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 1 of 107 · 2,132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEREMEDYREPACK INC.6d7ea8f7-981c-4acc-aeaf-7516325bfc0c2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078983
rxcui: 349591
unii: 57WVB6I2W0
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AtomoxetineATOMOXETINEREMEDYREPACK INC.d7002d75-edad-4141-91bf-7eebf50ad1aa2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 608139
unii: 57WVB6I2W0
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
atomoxetineATOMOXETINENorthstar Rx LLC133a4b65-762b-4712-baba-2442546f03792026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349593
rxcui: 349594
rxcui: 349595
rxcui: 608143
rxcui: 608139
rxcui: 349592
rxcui: 349591
unii: 57WVB6I2W0
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
atomoxetineATOMOXETINEGlenmark Pharmaceuticals Inc., USA0ab8d905-e890-4e91-a730-3e5d12f5c23f2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349593
rxcui: 349594
rxcui: 349595
rxcui: 608143
rxcui: 608139
rxcui: 349592
rxcui: 349591
unii: 57WVB6I2W0
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
AtomoxetineATOMOXETINEAurobindo Pharma Limited6f6bea0c-297b-43ff-8960-ecc11243e06e2026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349593
rxcui: 349594
rxcui: 349595
rxcui: 608143
rxcui: 608139
rxcui: 349592
rxcui: 349591
unii: 57WVB6I2W0

Reported adverse events (FAERS/openFDA)#

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