PAROXETINE

Product NDC
50090-5566
11-digit product format
500905566
Labeler code
50090
Product ID
50090-5566_e0e0a852-9cc1-4296-b8e9-60fdfab745f8
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
20 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
50090-5566-0PAROXETINE1 in 1 BLISTER PACKTABLET, FILM COATED11
50090-5566-0PAROXETINE32 in 1 BOX, UNIT-DOSETABLET, FILM COATED321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5566PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210727_6695399d-c645-4f67-9014-f32bcdca4ab6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN6695399d-c645-4f67-9014-f32bcdca4ab61
1738495paroxetine hydrochloride 20 MG Oral TabletSCD6695399d-c645-4f67-9014-f32bcdca4ab61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5566-05009055660032 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5566-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK32 blister pack2021-06-220000-00-00NoNoCurrent