FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
50268-059
11-digit product format
502680059
Labeler code
50268
Product ID
50268-059_4587bd5f-1bd2-c809-e063-6294a90adf87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA078983
Marketing category
ANDA
Marketing start
2020-07-07
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349595

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349595atomoxetine HCl 60 MG Oral CapsulePSNa9df4617-b406-70ba-e053-2995a90a28e82
349595atomoxetine 60 MG Oral CapsuleSCDa9df4617-b406-70ba-e053-2995a90a28e82
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSYa9df4617-b406-70ba-e053-2995a90a28e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-059-11502680059111 in 1 BLISTER PACKHistorical
50268-059-135026800591330 BLISTER PACK in 1 BOX (50268-059-13) / 1 CAPSULE in 1 BLISTER PACK (50268-059-11) 30 blister pack2020-07-070000-00-00NoNoCurrent