FDA.reportPublic FDA data

PAROXETINE

Product NDC
42858-703
11-digit product format
428580703
Labeler code
42858
Product ID
42858-703_9182de9d-25d0-4d69-b59a-af086213cd4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
ANDA209293
Marketing category
ANDA
Marketing start
2018-09-14
Marketing end
2026-07-31
Substance
PAROXETINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PAROXETINE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8

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
42858-703-03PAROXETINE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE309
42858-703-50PAROXETINE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-703PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]7Current NDC, Legacy NDC, 2 package rows20240614_f562ab1a-adb9-4154-81cd-ceb480234331.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN27729943-8046-4342-af60-bc1da229abac104
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD27729943-8046-4342-af60-bc1da229abac104
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY27729943-8046-4342-af60-bc1da229abac104
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSNf562ab1a-adb9-4154-81cd-ceb4802343319
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSNf562ab1a-adb9-4154-81cd-ceb4802343319
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSNf562ab1a-adb9-4154-81cd-ceb4802343319
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCDf562ab1a-adb9-4154-81cd-ceb4802343319
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCDf562ab1a-adb9-4154-81cd-ceb4802343319
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCDf562ab1a-adb9-4154-81cd-ceb4802343319
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSYf562ab1a-adb9-4154-81cd-ceb4802343319
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSYf562ab1a-adb9-4154-81cd-ceb4802343319
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSYf562ab1a-adb9-4154-81cd-ceb4802343319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42858-703-034285807030330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-03) 2018-09-142026-07-31NoNoCurrent
42858-703-5042858070350500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-50) 2018-09-142026-07-31NoNoCurrent