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 95 of 104 · 2,062 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMACA Natural Mineral Sunscreen SPF-50TITANIUM DIOXIDE, ZINC OXIDEPharmaca Integrative Pharmacy, Inc.51e6cd7a-5c9a-4666-9021-ade42eb064cd2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
VERTRA Premium Suncare SPF 30TITANIUM DIOXIDE, ZINC OXIDEEai-Jr286, Inc.720ca725-24ca-4b59-b640-afa9832386922023-11-05WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4c9ffd30-4799-475d-94cb-07ce3d5b36602023-11-04WarningsExact identifier
unii: 15FIX9V2JP
Youth 2 Activating BB Cream SPF 30 Light MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporatione51e38c9-cc9b-4af3-842d-41d0162f17ff2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
Youth 4 Activating BB Cream SPF 30 DarkZINC OXIDE, TITANIUM DIOXIDEShaklee Corporation63f7f8bd-02f0-4a13-bb1e-298754b24fce2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
Youth 1 Activating BB Cream SPF 30 LightZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationc9e05055-48ea-405d-b1d4-50b263d0dbf92023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Diorfe03fc14-4132-4dab-b013-d490764be0d42023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior968cfae7-89b6-4ef3-ab60-1c675b90c1512023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior775f4009-9fc2-475b-a141-b4b5e55421802023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior189f8767-f463-4c83-8a38-975ce8672b2a2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc59b4ece-0534-4072-afe8-2142a43c6bb22023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Diorcdc2a156-5ccd-4d40-98af-c529f0911a9e2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WPOCTINOXATE, TITANIUM DIOXIDEPARFUMS CHRISTIAN DIOR6ee0284e-739d-4aad-9352-9ea9c106efa42023-11-03WarningsExact identifier
unii: 15FIX9V2JP
AtomoxetineATOMOXETINEA-S Medication Solutions14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 608139
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEA-S Medication Solutions0782204e-56a3-4439-9fb8-194da94870492023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349594
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEA-S Medication Solutions96855061-440f-4c99-a152-cf8da8e2b1b32023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349595
unii: 57WVB6I2W0
AtomoxetineATOMOXETINEA-S Medication Solutionsaa109260-6d4c-429c-9957-19cbe0e344852023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349594
unii: 57WVB6I2W0
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact identifier
unii: 15FIX9V2JP
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
unii: 15FIX9V2JP
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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