PAROXETINE

Product NDC
50090-1296
11-digit product format
500901296
Labeler code
50090
Product ID
50090-1296_4c1d0b43-d359-4b13-ab58-7f3b1b109f2d
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
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
50090-1296-0PAROXETINE90 in 1 BOTTLETABLET, FILM COATED9014
50090-1296-1PAROXETINE30 in 1 BOTTLETABLET, FILM COATED3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1296-0EA - Each50090-129622d73a19-52af-4560-8ee6-76303abb5ac012018-11-06
50090-1296-1EA - Each50090-1296a87af33f-1b1b-4e85-8cf3-0dd932182a1512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1296PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Legacy NDC, 2 package rows20210611_83b19193-4db1-4365-a110-e8c67d792c21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN83b19193-4db1-4365-a110-e8c67d792c2114
1738495PARoxetine HCl 20 MG Oral TabletPSN83b19193-4db1-4365-a110-e8c67d792c2114
1738483paroxetine hydrochloride 10 MG Oral TabletSCD83b19193-4db1-4365-a110-e8c67d792c2114
1738495paroxetine hydrochloride 20 MG Oral TabletSCD83b19193-4db1-4365-a110-e8c67d792c2114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1296-05009012960090 TABLET, FILM COATED in 1 BOTTLE (50090-1296-0) 2014-11-280000-00-00NoNoCurrent
50090-1296-15009012960130 TABLET, FILM COATED in 1 BOTTLE (50090-1296-1) 2014-11-280000-00-00NoNoCurrent