FDA.reportPublic FDA data

Paroxetine

Product NDC
43353-713
11-digit product format
433530713
Labeler code
43353
Product ID
43353-713_85b2c456-e237-42da-aa5c-415dc3326154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078406
Marketing category
ANDA
Marketing start
2009-12-03
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
43353-713-15Paroxetine15 in 1 BOTTLETABLET, FILM COATED151
43353-713-45Paroxetine45 in 1 BOTTLETABLET, FILM COATED451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-713-45EA - Each43353-713db7f5b4c-e5a7-4b6e-af43-178fff9bc89612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-713PAROXETINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20180727_662223ec-3b9b-4a85-9680-789522363a7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN662223ec-3b9b-4a85-9680-789522363a7b1
1738495paroxetine hydrochloride 20 MG Oral TabletSCD662223ec-3b9b-4a85-9680-789522363a7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-713-154335307131515 TABLET, FILM COATED in 1 BOTTLE (43353-713-15) 2011-03-220000-00-00NoNoCurrent
43353-713-454335307134545 TABLET, FILM COATED in 1 BOTTLE (43353-713-45) 2018-05-020000-00-00NoNoCurrent