FDA.reportPublic FDA data

Strattera

Product NDC
68151-4485
11-digit product format
681514485
Labeler code
68151
Product ID
68151-4485_14eceffd-5c83-412c-a92c-16242be39f1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021411
Marketing category
NDA
Marketing start
2003-01-10
Marketing end
0000-00-00
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
18 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-4485-32020-01-31C16284748780-19d75b9cf-f017-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
68151-4485-3Strattera1 in 1 PACKAGECAPSULE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atomoxetine hydrochlorideACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
AtomoxetineACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4485STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140820_b080e703-3fab-4914-8529-ffaa59da693d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349592atomoxetine HCl 18 MG Oral CapsulePSNb080e703-3fab-4914-8529-ffaa59da693d2
352318Strattera 18 MG Oral CapsulePSNb080e703-3fab-4914-8529-ffaa59da693d2
352318atomoxetine 18 MG Oral Capsule [Strattera]SBDb080e703-3fab-4914-8529-ffaa59da693d2
349592atomoxetine 18 MG Oral CapsuleSCDb080e703-3fab-4914-8529-ffaa59da693d2
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSYb080e703-3fab-4914-8529-ffaa59da693d2
352318Strattera 18 MG Oral CapsuleSYb080e703-3fab-4914-8529-ffaa59da693d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4485-3681514485031 in 1 PACKAGEHistorical