Atomoxetine

Product NDC
50090-6144
11-digit product format
500906144
Labeler code
50090
Product ID
50090-6144_3378441e-e572-45a8-89d5-861d2e6cb11d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202682
Marketing category
ANDA
Marketing start
2021-03-11
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui608139

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
50090-6144-0Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6144-0EA - Each50090-6144ad55b241-d5f5-4e68-b6c8-d6e05cfbfa6e12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6144ATOMOXETINE (ATOMOXETINE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231102_14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608139atomoxetine HCl 100 MG Oral CapsulePSN14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa3
608139atomoxetine 100 MG Oral CapsuleSCD14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa3
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6144-05009061440030 CAPSULE in 1 BOTTLE (50090-6144-0) 30 capsule2022-10-040000-00-00NoNoCurrent