FDA.reportPublic FDA data

PAROXETINE

Product NDC
60505-0084
11-digit product format
605050084
Labeler code
60505
Product ID
60505-0084_9cde2ef4-fd50-ed21-0628-cb6cd8a6153f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-09-08
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
30 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 ANHYDROUS30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
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
60505-0084-1PAROXETINE30 in 1 BOTTLETABLET, FILM COATED3025
60505-0084-2PAROXETINE100 in 1 BOTTLETABLET, FILM COATED10025
60505-0084-4PAROXETINE1000 in 1 BOTTLETABLET, FILM COATED100025
60505-0084-5PAROXETINE10 in 1 BLISTER PACKTABLET, FILM COATED1025
60505-0084-5PAROXETINE10 in 1 CARTONTABLET, FILM COATED1025
60505-0084-9PAROXETINE90 in 1 BOTTLETABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0084-1EA - Each60505-008459db11de-be77-4ee6-824c-bee7a731908d12012-07-24
60505-0084-2EA - Each60505-0084fa059b40-4016-416f-ae3f-8c908078b66612012-07-24
60505-0084-4EA - Each60505-0084e797d8aa-cb58-446d-a66a-41073b54f06112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]11
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE TABLET, FILM COATED [DIRECTRX]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [DIRECTRX]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET, FILM COATED [DIRECTRX]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE TABLET, FILM COATED [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0084PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]24Current NDC, Legacy NDC, 6 package rows20250411_08320ea3-8f93-6f04-5d1c-f69af3eb5a81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738495PARoxetine HCl 20 MG Oral TabletPSN08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738503PARoxetine HCl 30 MG Oral TabletPSN08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738511PARoxetine HCl 40 MG Oral TabletPSN08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738483paroxetine hydrochloride 10 MG Oral TabletSCD08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738495paroxetine hydrochloride 20 MG Oral TabletSCD08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738503paroxetine hydrochloride 30 MG Oral TabletSCD08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738511paroxetine hydrochloride 40 MG Oral TabletSCD08320ea3-8f93-6f04-5d1c-f69af3eb5a8125
1738483PARoxetine HCl 10 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738495PARoxetine HCl 20 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738503PARoxetine HCl 30 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738511PARoxetine HCl 40 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738483paroxetine hydrochloride 10 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738495paroxetine hydrochloride 20 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738503paroxetine hydrochloride 30 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738511paroxetine hydrochloride 40 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738503PARoxetine HCl 30 MG Oral TabletPSN8e176ff2-ed3a-4909-94e1-6b9a3581a62118
1738503paroxetine hydrochloride 30 MG Oral TabletSCD8e176ff2-ed3a-4909-94e1-6b9a3581a62118
1738483PARoxetine HCl 10 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738495PARoxetine HCl 20 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738503PARoxetine HCl 30 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738511PARoxetine HCl 40 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738483paroxetine hydrochloride 10 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738495paroxetine hydrochloride 20 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738503paroxetine hydrochloride 30 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738511paroxetine hydrochloride 40 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738483PARoxetine HCl 10 MG Oral TabletPSNa93796a3-56fc-4af6-99ba-f76707c32e5d5
1738495PARoxetine HCl 20 MG Oral TabletPSNa93796a3-56fc-4af6-99ba-f76707c32e5d5
1738511PARoxetine HCl 40 MG Oral TabletPSNa93796a3-56fc-4af6-99ba-f76707c32e5d5
1738483paroxetine hydrochloride 10 MG Oral TabletSCDa93796a3-56fc-4af6-99ba-f76707c32e5d5
1738495paroxetine hydrochloride 20 MG Oral TabletSCDa93796a3-56fc-4af6-99ba-f76707c32e5d5
1738511paroxetine hydrochloride 40 MG Oral TabletSCDa93796a3-56fc-4af6-99ba-f76707c32e5d5
1738503PARoxetine HCl 30 MG Oral TabletPSN79b0eb99-95f8-4db4-ba30-503f32538ab83
1738503paroxetine hydrochloride 30 MG Oral TabletSCD79b0eb99-95f8-4db4-ba30-503f32538ab83
1738483PARoxetine HCl 10 MG Oral TabletPSNc9b57101-2455-463d-b8d7-b2316cecd67a1
1738495PARoxetine HCl 20 MG Oral TabletPSNc9b57101-2455-463d-b8d7-b2316cecd67a1
1738503PARoxetine HCl 30 MG Oral TabletPSNc9b57101-2455-463d-b8d7-b2316cecd67a1
1738511PARoxetine HCl 40 MG Oral TabletPSNc9b57101-2455-463d-b8d7-b2316cecd67a1
1738483paroxetine hydrochloride 10 MG Oral TabletSCDc9b57101-2455-463d-b8d7-b2316cecd67a1
1738495paroxetine hydrochloride 20 MG Oral TabletSCDc9b57101-2455-463d-b8d7-b2316cecd67a1
1738503paroxetine hydrochloride 30 MG Oral TabletSCDc9b57101-2455-463d-b8d7-b2316cecd67a1
1738511paroxetine hydrochloride 40 MG Oral TabletSCDc9b57101-2455-463d-b8d7-b2316cecd67a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0084-16050500840130 TABLET, FILM COATED in 1 BOTTLE (60505-0084-1) 2003-09-080000-00-00NoNoCurrent
60505-0084-260505008402100 TABLET, FILM COATED in 1 BOTTLE (60505-0084-2) 2003-09-080000-00-00NoNoCurrent
60505-0084-4605050084041000 TABLET, FILM COATED in 1 BOTTLE (60505-0084-4) 2003-09-080000-00-00NoNoCurrent
60505-0084-56050500840510 BLISTER PACK in 1 CARTON (60505-0084-5) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2003-09-080000-00-00NoNoCurrent
60505-0084-96050500840990 TABLET, FILM COATED in 1 BOTTLE (60505-0084-9) 2003-09-080000-00-00NoNoCurrent