FDA.reportPublic FDA data

Paroxetine

Product NDC
71209-095
11-digit product format
712090095
Labeler code
71209
Product ID
71209-095_03756846-6e37-4c43-9a84-58e06801336a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA212645
Marketing category
ANDA
Marketing start
2020-02-14
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
25 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 HEMIHYDRATE25 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
71209-095-01Paroxetine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307
71209-095-10Paroxetine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-095PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE [CADILA PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 2 package rows20240405_5e43cdbd-2419-434b-96b9-920f02558d1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN5e43cdbd-2419-434b-96b9-920f02558d1c7
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN5e43cdbd-2419-434b-96b9-920f02558d1c7
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN5e43cdbd-2419-434b-96b9-920f02558d1c7
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD5e43cdbd-2419-434b-96b9-920f02558d1c7
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD5e43cdbd-2419-434b-96b9-920f02558d1c7
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD5e43cdbd-2419-434b-96b9-920f02558d1c7
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY5e43cdbd-2419-434b-96b9-920f02558d1c7
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY5e43cdbd-2419-434b-96b9-920f02558d1c7
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY5e43cdbd-2419-434b-96b9-920f02558d1c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-095-017120900950130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-095-01) 2020-02-140000-00-00NoNoCurrent
71209-095-1071209009510500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-095-10) 2020-02-140000-00-00NoNoCurrent