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 90 of 104 · 2,062 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3LAB PERFECT Lite Sunscreen SPF 30 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDE3LAB, Inc3052af3f-8923-47bc-be6e-17396275363a2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Isa SunGuard SPF 30ZINC OXIDE, TITANIUM DIOXIDEIsagenix International, LLCabe1e345-6ea2-43b3-8613-b5b5e04c87b72023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5169b10e-5a8d-479a-a6a8-1e7a13cb70c42023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20TITANIUM DIOXIDEBoscia LLCf76166f1-e987-4eaf-8192-14dc08c481f72023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBoscia LLC2a6b507f-0967-46e1-8360-0003772f1bdb2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01TITANIUM DIOXIDE3LAB, Inc.703dc828-24b4-4f04-9f2c-4a2edfdf46322023-12-12WarningsExact identifier
unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02TITANIUM DIOXIDE3LAB, Inc.7c6c7062-91f7-4304-98c3-f77967a2d3292023-12-12WarningsExact identifier
unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 01TITANIUM DIOXIDE3LAB, Incbd39d2fb-8326-4e19-b634-7a7308313d8a2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 03TITANIUM DIOXIDE3LAB, Inc19884289-edb2-4d18-bd62-873533b94a102023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.92dc1a86-590e-4144-9d30-172645e631402023-12-12WarningsExact identifier
unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 02TITANIUM DIOXIDE3LAB, Incbf4419b9-408d-469a-aa15-bbf419632f022023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily SkinTITANIUM DIOXIDE, ZINC OXIDELikewise Incorporated28b8c519-8417-427e-8d4f-94da44a69d9f2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.c06ecc56-2044-4396-8acd-6d18af9b984c2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.f5c7b7ce-b3ed-3e96-e053-2995a90a8ea92023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight SunscreenTITANIUM DIOXIDECosmetique Active Productionacb887bc-7e46-4257-9fe3-a2cade6c4f382023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Solar Defense TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ec4-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Solar Defense Non TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ea1-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Erborian BB creme au Ginseng chocolate SPF 20OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lddcd6ea4-e7b1-88df-e053-2a95a90a99232023-12-09WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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