atomoxetine

Product NDC
50090-7342
11-digit product format
500907342
Labeler code
50090
Product ID
50090-7342_c6e62eb1-c864-4e73-8908-0d3646ba58cf
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
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
50090-7342-0atomoxetine30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7342-0EA - Each50090-7342920b228b-4975-4a69-b557-1ab6a062b88f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7342ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241023_47f6faeb-52b5-4b04-bf34-de5db8eb46dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN47f6faeb-52b5-4b04-bf34-de5db8eb46dc1
349593atomoxetine 25 MG Oral CapsuleSCD47f6faeb-52b5-4b04-bf34-de5db8eb46dc1
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY47f6faeb-52b5-4b04-bf34-de5db8eb46dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7342-05009073420030 CAPSULE in 1 BOTTLE (50090-7342-0) 30 capsule2024-10-16NoNoCurrent