atomoxetine

Product NDC
50090-7463
11-digit product format
500907463
Labeler code
50090
Product ID
50090-7463_2cc8f0a2-9b6a-4ddd-8fcb-2742cfbd13a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079019
Marketing category
ANDA
Marketing start
2017-05-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
atomoxetine
Listing expiration
2027-12-31

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
50090-7463-0atomoxetine30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7463-0EA - Each50090-74632a809d6a-6033-4f23-bc64-b7d51de0800612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7463ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241122_90f45a1e-f79f-468f-b21b-5dc82f5717aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608139atomoxetine HCl 100 MG Oral CapsulePSN90f45a1e-f79f-468f-b21b-5dc82f5717aa4
608139atomoxetine 100 MG Oral CapsuleSCD90f45a1e-f79f-468f-b21b-5dc82f5717aa4
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY90f45a1e-f79f-468f-b21b-5dc82f5717aa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7463-05009074630030 CAPSULE in 1 BOTTLE (50090-7463-0) 30 capsule2024-11-19NoNoCurrent