Atomoxetine Hydrochloride

Product NDC
50090-4235
11-digit product format
500904235
Labeler code
50090
Product ID
50090-4235_01334492-c8c9-4962-825f-d0b6cb88f8ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078983
Marketing category
ANDA
Marketing start
2018-05-21
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4235-0Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4235ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20220316_3d334d3f-dc7f-4eeb-a5f0-41e660f36a13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN3d334d3f-dc7f-4eeb-a5f0-41e660f36a137
349593atomoxetine 25 MG Oral CapsuleSCD3d334d3f-dc7f-4eeb-a5f0-41e660f36a137
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY3d334d3f-dc7f-4eeb-a5f0-41e660f36a137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4235-05009042350030 CAPSULE in 1 BOTTLE (50090-4235-0) 30 capsule2019-03-290000-00-00NoNoCurrent