Paroxetine

Product NDC
50090-2143
11-digit product format
500902143
Labeler code
50090
Product ID
50090-2143_67dd70df-0747-4d04-ae19-6fda76e9a147
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078406
Marketing category
ANDA
Marketing start
2009-12-03
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
10 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
50090-2143-0Paroxetine90 in 1 BOTTLETABLET, FILM COATED9012
50090-2143-1Paroxetine30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2143PAROXETINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Legacy NDC, 2 package rows20210616_ec4e1e42-713c-41ea-b62d-2f46b8b5be05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNec4e1e42-713c-41ea-b62d-2f46b8b5be0512
1738495PARoxetine HCl 20 MG Oral TabletPSNec4e1e42-713c-41ea-b62d-2f46b8b5be0512
1738483paroxetine hydrochloride 10 MG Oral TabletSCDec4e1e42-713c-41ea-b62d-2f46b8b5be0512
1738495paroxetine hydrochloride 20 MG Oral TabletSCDec4e1e42-713c-41ea-b62d-2f46b8b5be0512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2143-05009021430090 TABLET, FILM COATED in 1 BOTTLE (50090-2143-0) 2015-10-200000-00-00NoNoCurrent
50090-2143-15009021430130 TABLET, FILM COATED in 1 BOTTLE (50090-2143-1) 2015-10-200000-00-00NoNoCurrent