FDA.reportPublic FDA data

Paroxetine

Product NDC
72241-031
11-digit product format
722410031
Labeler code
72241
Product ID
72241-031_1d6895c1-d0ec-48f1-ad90-5c16d582a049
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA212645
Marketing category
ANDA
Marketing start
2021-10-20
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
37.5 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 HEMIHYDRATE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738803, 1738805, 1738807

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
72241-031-10Paroxetine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005
72241-031-22Paroxetine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-031-22EA - Each72241-031b0ddefc2-72c9-4f21-9da7-47848f87417912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-031PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE [MODAVAR PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20240425_555cfa31-3865-450f-b16b-2f4004af7a67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN555cfa31-3865-450f-b16b-2f4004af7a675
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN555cfa31-3865-450f-b16b-2f4004af7a675
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN555cfa31-3865-450f-b16b-2f4004af7a675
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD555cfa31-3865-450f-b16b-2f4004af7a675
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD555cfa31-3865-450f-b16b-2f4004af7a675
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD555cfa31-3865-450f-b16b-2f4004af7a675
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY555cfa31-3865-450f-b16b-2f4004af7a675
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY555cfa31-3865-450f-b16b-2f4004af7a675
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY555cfa31-3865-450f-b16b-2f4004af7a675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72241-031-1072241003110500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-10) 2021-10-200000-00-00NoNoCurrent
72241-031-227224100312230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-22) 2021-10-200000-00-00NoNoCurrent