Atomoxetine

Product NDC
50090-6143
11-digit product format
500906143
Labeler code
50090
Product ID
50090-6143_a726ffd7-e7bd-4005-8b8a-b4d9bb58b67f
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
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
50090-6143-0Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6143-0EA - Each50090-6143ecf72126-79be-4dab-8a96-08eeb3583ebe12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6143ATOMOXETINE (ATOMOXETINE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231102_0782204e-56a3-4439-9fb8-194da9487049.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSN0782204e-56a3-4439-9fb8-194da94870493
349594atomoxetine 40 MG Oral CapsuleSCD0782204e-56a3-4439-9fb8-194da94870493
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY0782204e-56a3-4439-9fb8-194da94870493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6143-05009061430030 CAPSULE in 1 BOTTLE (50090-6143-0) 30 capsule2022-10-040000-00-00NoNoCurrent