Atomoxetine

Product NDC
50090-6703
11-digit product format
500906703
Labeler code
50090
Product ID
50090-6703_007e984f-3d1a-4ba8-840d-e10433010cf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349593

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
50090-6703-0Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6703ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231002_50a20478-5f33-4ecd-b5d3-dbba855e5f6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN50a20478-5f33-4ecd-b5d3-dbba855e5f6b3
349593atomoxetine 25 MG Oral CapsuleSCD50a20478-5f33-4ecd-b5d3-dbba855e5f6b3
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY50a20478-5f33-4ecd-b5d3-dbba855e5f6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6703-05009067030030 CAPSULE in 1 BOTTLE (50090-6703-0) 30 capsule2023-09-26NoNoHistorical