FDA.reportPublic FDA data

Atomoxetine

Product NDC
71335-9702
11-digit product format
713359702
Labeler code
71335
Product ID
71335-9702_db2a7ba8-e0ef-43df-a695-4117f3b7efdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-05-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9702-1Atomoxetine30 in 1 BOTTLECAPSULE30104
71335-9702-2Atomoxetine60 in 1 BOTTLECAPSULE60104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9702ATOMOXETINE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240410_35b42f0c-a183-478b-bced-652dc12b33ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349595atomoxetine HCl 60 MG Oral CapsulePSN35b42f0c-a183-478b-bced-652dc12b33ec104
349595atomoxetine 60 MG Oral CapsuleSCD35b42f0c-a183-478b-bced-652dc12b33ec104
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY35b42f0c-a183-478b-bced-652dc12b33ec104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9702-17133597020130 CAPSULE in 1 BOTTLE (71335-9702-1) 30 capsule2023-04-28NoNoHistorical
71335-9702-27133597020260 CAPSULE in 1 BOTTLE (71335-9702-2) 60 capsule2026-04-10NoNoHistorical