FDA.reportPublic FDA data

Strattera

Product NDC
64725-3228
11-digit product format
647253228
Labeler code
64725
Product ID
64725-3228_418efa18-077c-43db-9b9a-ce25d59d4e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
NDA021411
Marketing category
NDA
Marketing start
2003-01-10
Marketing end
0000-00-00
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
64725-3228-12020-01-31C16284748780-19d75b9d0-e8fc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use STRATTERA safely and effectively. See full prescribing information for STRATTERA. STRATTERA (atomoxetine) CAPSULES for Oral Use Initial U.S. Approval: 2002 ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-3228-1Strattera30 in 1 BOTTLECAPSULE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atomoxetine hydrochlorideACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
AtomoxetineACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-3228STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141025_fd1c71bc-1445-4ac6-8a8d-79050e61b03a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSNfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
352319Strattera 25 MG Oral CapsulePSNfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
352319atomoxetine 25 MG Oral Capsule [Strattera]SBDfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
349593atomoxetine 25 MG Oral CapsuleSCDfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSYfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
352319Strattera 25 MG Oral CapsuleSYfd1c71bc-1445-4ac6-8a8d-79050e61b03a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-3228-16472532280130 in 1 BOTTLEHistorical