Paroxetine

Product NDC
51655-356
11-digit product format
516550356
Labeler code
51655
Product ID
51655-356_d4792b1b-f6c3-5b55-e053-2a95a90a0d35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA077584
Marketing category
ANDA
Marketing start
2020-05-28
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-356-252023-01-30C16284748780-1f386c649-9959-0266-e053-dadaa90a7c1aParoxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-356-25Paroxetine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-356PAROXETINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20220101_ab6c4a4b-97b3-3631-e053-2a95a90a614a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSNab6c4a4b-97b3-3631-e053-2a95a90a614a2
1738495paroxetine hydrochloride 20 MG Oral TabletSCDab6c4a4b-97b3-3631-e053-2a95a90a614a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-356-255165503562560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-356-25) 2020-05-280000-00-00NoNoCurrent