FDA.reportPublic FDA data

Paroxetine

Product NDC
55289-972
11-digit product format
552890972
Labeler code
55289
Product ID
55289-972_419e8187-78f3-42a9-e063-6294a90a6680
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738495

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
55289-972-30Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
55289-972-60Paroxetine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023
55289-972-90Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-972PAROXETINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 3 package rows20240315_c0acc97d-3d8d-4a7f-8acd-99050b0af2f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSNc0acc97d-3d8d-4a7f-8acd-99050b0af2f123
1738495paroxetine hydrochloride 20 MG Oral TabletSCDc0acc97d-3d8d-4a7f-8acd-99050b0af2f123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-972-305528909723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-30) 2016-02-100000-00-00NoNoCurrent
55289-972-605528909726060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-60) 2016-02-100000-00-00NoNoCurrent
55289-972-905528909729090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-90) 2016-02-100000-00-00NoNoCurrent