FDA.reportPublic FDA data

NDC 50268-059-11 - 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
50268-059
Requested NDC
50268-059-11
Package NDCs from labels
50268-059-11, 50268-059-13
Manufacturer
AvPAK
Effective date
2025-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atomoxetine Hydrochloride - AvPAKAvPAK2025-12-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-059-132025-12-09C16284748780-1d6a99b39-5c9e-a426-e053-dadaa90af4c2ATOMOXETINE capsules, for oral use These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . Initial U.S. Approval: 2002
50268-059-132022-01-28C16284748780-1d6a99b39-5c9e-a426-e053-dadaa90af4c2ATOMOXETINE capsules, for oral use These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-059-11Atomoxetine Hydrochloride1 in 1 BLISTER PACKCAPSULE12
50268-059-13Atomoxetine Hydrochloride30 in 1 BOXCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-059ATOMOXETINE HYDROCHLORIDE CAPSULE [AVPAK]1Current NDC, Legacy NDC, 2 package rows20200708_a9df4617-b406-70ba-e053-2995a90a28e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-059-11EA - Each50268-05970c65c2c-c5d9-4ed1-90f7-11ef00cec29912020-08-06
50268-059-13EA - Each50268-059354c0c74-bb98-4916-a29a-e8a388325f6312020-08-06

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 23 of 104 · 2,073 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
unii: 15FIX9V2JP
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
unii: 15FIX9V2JP
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
unii: 15FIX9V2JP
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4743b6a9-4d79-1b2b-e063-6394a90a97102025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4744e501-f12a-6d25-e063-6394a90a25742025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47456bf5-9f6c-e6a5-e063-6294a90a70542025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ab56-abaa-42de-e063-6394a90a63102025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ebec-acb0-77c4-e063-6394a90aee072025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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