Atomoxetine

Product NDC
50090-6254
11-digit product format
500906254
Labeler code
50090
Product ID
50090-6254_68d542a1-d983-491f-8cac-1f32631b523a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079022
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
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 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
50090-6254-0Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6254-0EA - Each50090-6254b0647ed6-d9f4-4548-b3bf-21feda0eb21712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6254ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231101_96855061-440f-4c99-a152-cf8da8e2b1b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349595atomoxetine HCl 60 MG Oral CapsulePSN96855061-440f-4c99-a152-cf8da8e2b1b33
349595atomoxetine 60 MG Oral CapsuleSCD96855061-440f-4c99-a152-cf8da8e2b1b33
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY96855061-440f-4c99-a152-cf8da8e2b1b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6254-05009062540030 CAPSULE in 1 BOTTLE (50090-6254-0) 30 capsule2022-12-020000-00-00NoNoCurrent