Paroxetine

Product NDC
50268-641
11-digit product format
502680641
Labeler code
50268
Product ID
50268-641_6d87e193-a013-3fbc-e053-2a91aa0ac828
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078406
Marketing category
ANDA
Marketing start
2016-03-11
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-641-11Paroxetine1 in 1 BLISTER PACKTABLET, FILM COATED19
50268-641-15Paroxetine50 in 1 BOX, UNIT-DOSETABLET, FILM COATED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-641-11EA - Each50268-641d3b25ec4-27e8-4148-85cd-53cfaca78f3f12016-04-04
50268-641-15EA - Each50268-64177a09070-2445-4521-8428-2a729cdad1f112016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-641PAROXETINE TABLET, FILM COATED [AVPAK]7Legacy NDC, 2 package rows20220507_d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738495PARoxetine HCl 20 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738503PARoxetine HCl 30 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738511PARoxetine HCl 40 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738483paroxetine hydrochloride 10 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738495paroxetine hydrochloride 20 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738503paroxetine hydrochloride 30 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738511paroxetine hydrochloride 40 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50268-641-11502680641111 in 1 BLISTER PACKHistorical
50268-641-155026806411550 in 1 BOX, UNIT-DOSEHistorical