PAROXETINE

Product NDC
61919-596
11-digit product format
619190596
Labeler code
61919
Product ID
61919-596_86e4198d-f602-2df4-e053-2a91aa0a201e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA077584
Marketing category
ANDA
Marketing start
2019-04-19
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
30 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
61919-596-302024-01-30C16284748780-11030e365-1bce-111a-e063-dadaa90a10e2PAROXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-596-30PAROXETINE30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-596PAROXETINE TABLET, FILM COATED [DIRECTRX]3Legacy NDC, 1 package rows20190420_79b0eb99-95f8-4db4-ba30-503f32538ab8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738503PARoxetine HCl 30 MG Oral TabletPSN79b0eb99-95f8-4db4-ba30-503f32538ab83
1738503paroxetine hydrochloride 30 MG Oral TabletSCD79b0eb99-95f8-4db4-ba30-503f32538ab83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-596-306191905963030 TABLET, FILM COATED in 1 BOTTLE (61919-596-30) 2019-04-190000-00-00NoNoCurrent