FDA.reportPublic FDA data

PAROXETINE

Product NDC
67544-492
11-digit product format
675440492
Labeler code
67544
Product ID
67544-492_1bb37fe5-45ba-4f89-b480-35fa1dedf247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-09-08
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
40 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 ANHYDROUS40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
Rxcui1738511

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
67544-492-15PAROXETINE15 in 1 BOTTLETABLET, FILM COATED151
67544-492-30PAROXETINE30 in 1 BOTTLETABLET, FILM COATED301
67544-492-45PAROXETINE45 in 1 BOTTLETABLET, FILM COATED451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-492-15EA - Each67544-4924e32cfc5-aea6-47bb-9e37-b5cafefa4f7a12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-492PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20181023_a7128be7-7023-40c4-aa64-29d52145ae31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSNa7128be7-7023-40c4-aa64-29d52145ae311
1738511paroxetine hydrochloride 40 MG Oral TabletSCDa7128be7-7023-40c4-aa64-29d52145ae311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-492-156754404921515 TABLET, FILM COATED in 1 BOTTLE (67544-492-15) 2018-07-100000-00-00NoNoCurrent
67544-492-306754404923030 TABLET, FILM COATED in 1 BOTTLE (67544-492-30) 2018-07-100000-00-00NoNoCurrent
67544-492-456754404924545 TABLET, FILM COATED in 1 BOTTLE (67544-492-45) 2018-07-100000-00-00NoNoCurrent