Paroxetine

Product NDC
52959-776
11-digit product format
529590776
Labeler code
52959
Product ID
52959-776_176f9d8a-7d2d-4830-abe6-91e32cdf58f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
52959-776-302019-11-13C16284748780-197449f38-d319-f6ea-e053-dbdaa90aa703Paroxetine Tablets, USP
52959-776-602019-11-13C16284748780-197449f38-d319-f6ea-e053-dbdaa90aa703Paroxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-776-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED302
52959-776-60Paroxetine60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-776PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20111230_16348d76-055f-4a7a-9de9-00144c9ee339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN16348d76-055f-4a7a-9de9-00144c9ee3392
1738495PARoxetine HCl 20 MG Oral TabletPSN16348d76-055f-4a7a-9de9-00144c9ee3392
1738483paroxetine hydrochloride 10 MG Oral TabletSCD16348d76-055f-4a7a-9de9-00144c9ee3392
1738495paroxetine hydrochloride 20 MG Oral TabletSCD16348d76-055f-4a7a-9de9-00144c9ee3392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-776-305295907763030 in 1 BOTTLEHistorical
52959-776-605295907766060 in 1 BOTTLEHistorical