Paroxetine

Product NDC
64725-0197
11-digit product format
647250197
Labeler code
64725
Product ID
64725-0197_1c0a7105-b561-472a-aa52-5593386181f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
10 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
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
64725-0197-12020-01-31C16284748780-19d75b9d0-409f-f424-e053-dadaa90a57ceParoxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0197-1Paroxetine60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0197PAROXETINE TABLET, FILM COATED [TYA PHARMACEUTICALS]5Legacy NDC, 1 package rows20160618_4f5c2c98-7936-4565-ac32-c432a7f2237e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN4f5c2c98-7936-4565-ac32-c432a7f2237e5
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4f5c2c98-7936-4565-ac32-c432a7f2237e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0197-16472501970160 in 1 BOTTLEHistorical