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 27 of 104 · 2,073 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc87e5201-f7fd-4fd9-adeb-d6af9be00db62025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior84cdaad2-5b7d-4841-bef6-ffad4fe6907a2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb4caa2bc-8118-4137-8834-25800f8e5e012025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc0fa32fe-faa7-4a47-906c-14db01e55d472025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff1a8b32-c01f-4910-9a7a-c74eb49c05a02025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord3bd710b-7d1a-4f96-9fbc-a67c550d863b2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior3b6ea0ec-4636-43cf-a324-a82666108e952025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ac7fb96-a2f2-4086-82ad-c45d7a7090912025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior84a5f7e1-1c04-43cd-8d3b-60c7e2418faf2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28a61b11-5901-47ec-916c-e2ae4f79a11d2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ddf8221-9bfc-4c52-9a51-a0d725b7a23e2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5937248a-b96e-490a-9f93-10e65969ac102025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior62136c4c-6f05-4de0-a71e-55aa531606852025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora8037741-ec57-43e7-adb4-2a93941ee1082025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6f872199-067e-40aa-bf34-549ecc33b1ac2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior938a5c4a-b9dd-4089-8b20-7030f032591d2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1357ab72-0d73-41da-8f55-7bd6d97c9ae82025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d63bdc5-5338-48c4-9c59-bfb9900ab9202025-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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