FDA.reportPublic FDA data

PAROXETINE

Product NDC
61919-658
11-digit product format
619190658
Labeler code
61919
Product ID
61919-658_f2152dab-c7ce-3e59-e053-2995a90a3120
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077584
Marketing category
ANDA
Marketing start
2019-04-19
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-658-302025-01-30C16284748780-12cef2736-73ca-d83d-e063-dadaa90ab31fPAROXETINE
61919-658-602025-01-30C16284748780-12cef2736-73ca-d83d-e063-dadaa90ab31fPAROXETINE
61919-658-902025-01-30C16284748780-12cef2736-73ca-d83d-e063-dadaa90ab31fPAROXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-658-30PAROXETINE30 in 1 BOTTLETABLET, FILM COATED309
61919-658-60PAROXETINE60 in 1 BOTTLETABLET, FILM COATED609
61919-658-90PAROXETINE90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-658PAROXETINE TABLET, FILM COATED [DIRECT RX]9Legacy NDC, 3 package rows20230511_fce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
1738495PARoxetine HCl 20 MG Oral TabletPSNfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
1738483paroxetine hydrochloride 10 MG Oral TabletSCDfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
1738495paroxetine hydrochloride 20 MG Oral TabletSCDfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-658-306191906583030 TABLET, FILM COATED in 1 BOTTLE (61919-658-30) 2019-04-190000-00-00NoNoCurrent
61919-658-606191906586060 TABLET, FILM COATED in 1 BOTTLE (61919-658-60) 2019-04-190000-00-00NoNoCurrent
61919-658-906191906589090 TABLET, FILM COATED in 1 BOTTLE (61919-658-90) 2019-04-190000-00-00NoNoCurrent