FDA.reportPublic FDA data

Paroxetine

Product NDC
65862-154
11-digit product format
658620154
Labeler code
65862
Product ID
65862-154_19f7a08f-58bd-45b8-a750-4432ae161455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078406
Marketing category
ANDA
Marketing start
2007-07-25
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
10 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 HEMIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483, 1738495, 1738503, 1738511

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
65862-154-01Paroxetine100 in 1 BOTTLETABLET, FILM COATED10024
65862-154-05Paroxetine500 in 1 BOTTLETABLET, FILM COATED50024
65862-154-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED3024
65862-154-90Paroxetine90 in 1 BOTTLETABLET, FILM COATED9024
65862-154-99Paroxetine1000 in 1 BOTTLETABLET, FILM COATED100024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-154PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 5 package rows20250124_326e8ab0-6886-4749-9544-885b37070051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738495PARoxetine HCl 20 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738503PARoxetine HCl 30 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738511PARoxetine HCl 40 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738483paroxetine hydrochloride 10 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738495paroxetine hydrochloride 20 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738503paroxetine hydrochloride 30 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738511paroxetine hydrochloride 40 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738483PARoxetine HCl 10 MG Oral TabletPSN695bc7cc-ae91-4190-b5d6-94295d6686731
1738483paroxetine hydrochloride 10 MG Oral TabletSCD695bc7cc-ae91-4190-b5d6-94295d6686731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-154-0165862015401100 TABLET, FILM COATED in 1 BOTTLE (65862-154-01) 2007-07-250000-00-00NoNoCurrent
65862-154-0565862015405500 TABLET, FILM COATED in 1 BOTTLE (65862-154-05) 2007-07-250000-00-00NoNoCurrent
65862-154-306586201543030 TABLET, FILM COATED in 1 BOTTLE (65862-154-30) 2007-07-250000-00-00NoNoCurrent
65862-154-59658620154595000 TABLET, FILM COATED in 1 BAG (65862-154-59)25-JUL-07Current
65862-154-906586201549090 TABLET, FILM COATED in 1 BOTTLE (65862-154-90) 2007-07-250000-00-00NoNoCurrent
65862-154-99658620154991000 TABLET, FILM COATED in 1 BOTTLE (65862-154-99) 2007-07-250000-00-00NoNoCurrent