Atomoxetine Hydrochloride

Product NDC
50090-4243
11-digit product format
500904243
Labeler code
50090
Product ID
50090-4243_3f82534e-1d3b-4707-a042-5832b649d7a8
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
80 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-4243-0Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4243ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210617_8b7637ba-0541-41ef-bb54-1940fbbb8c64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608143atomoxetine HCl 80 MG Oral CapsulePSN8b7637ba-0541-41ef-bb54-1940fbbb8c647
608143atomoxetine 80 MG Oral CapsuleSCD8b7637ba-0541-41ef-bb54-1940fbbb8c647
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY8b7637ba-0541-41ef-bb54-1940fbbb8c647

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4243-05009042430030 CAPSULE in 1 BOTTLE (50090-4243-0) 30 capsule2019-03-290000-00-00NoNoCurrent