Atomoxetine

Product NDC
71335-2162
11-digit product format
713352162
Labeler code
71335
Product ID
71335-2162_3767a887-2273-a522-e063-6394a90a3fbc
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
40 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349594

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
71335-2162-1Atomoxetine30 in 1 BOTTLECAPSULE30104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2162ATOMOXETINE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240420_d4fe9217-1853-4f8b-9a93-77e511554ca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSNd4fe9217-1853-4f8b-9a93-77e511554ca1104
349594atomoxetine 40 MG Oral CapsuleSCDd4fe9217-1853-4f8b-9a93-77e511554ca1104
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYd4fe9217-1853-4f8b-9a93-77e511554ca1104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2162-17133521620130 CAPSULE in 1 BOTTLE (71335-2162-1) 30 capsule2022-09-070000-00-00NoNoCurrent