PAROXETINE

Product NDC
50090-0922
11-digit product format
500900922
Labeler code
50090
Product ID
50090-0922_fbbc69b1-5c09-49ca-a660-492a2acabcb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-09-08
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin 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
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0922-0PAROXETINE30 in 1 BOTTLETABLET, FILM COATED3010
50090-0922-1PAROXETINE90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0922PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20210327_d1909594-481b-456a-b302-a66ff42f8bd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSNd1909594-481b-456a-b302-a66ff42f8bd510
1738511paroxetine hydrochloride 40 MG Oral TabletSCDd1909594-481b-456a-b302-a66ff42f8bd510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0922-05009009220030 TABLET, FILM COATED in 1 BOTTLE (50090-0922-0) 2014-11-280000-00-00NoNoCurrent
50090-0922-15009009220190 TABLET, FILM COATED in 1 BOTTLE (50090-0922-1) 2014-11-280000-00-00NoNoCurrent