FDA.reportPublic FDA data

PAROXETINE

Product NDC
60505-0097
11-digit product format
605050097
Labeler code
60505
Product ID
60505-0097_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
10 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 ANHYDROUS10 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
60505-0097-1PAROXETINE30 in 1 BOTTLETABLET, FILM COATED3025
60505-0097-2PAROXETINE100 in 1 BOTTLETABLET, FILM COATED10025
60505-0097-4PAROXETINE1000 in 1 BOTTLETABLET, FILM COATED100025
60505-0097-5PAROXETINE10 in 1 BLISTER PACKTABLET, FILM COATED1025
60505-0097-5PAROXETINE10 in 1 CARTONTABLET, FILM COATED1025
60505-0097-7PAROXETINE18000 in 1 BOTTLETABLET, FILM COATED1800025
60505-0097-9PAROXETINE90 in 1 BOTTLETABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0097-1EA - Each60505-0097a06b67b3-821e-4aa1-8776-90ba1729b62f12012-07-24
60505-0097-2EA - Each60505-0097e2affb74-c713-4b5e-8030-89a01686829312012-07-24
60505-0097-4EA - Each60505-0097d759045a-6992-4195-8228-e632a2b2109912012-07-24

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
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]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 [TYA PHARMACEUTICALS]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
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [TYA PHARMACEUTICALS]4
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE TABLET, FILM COATED [DIRECT RX]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET, FILM COATED [DIRECT RX]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE TABLET, FILM COATED [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0097PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]24Current NDC, Legacy NDC, 7 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
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 TabletPSN83b19193-4db1-4365-a110-e8c67d792c2114
1738495PARoxetine HCl 20 MG Oral TabletPSN83b19193-4db1-4365-a110-e8c67d792c2114
1738483paroxetine hydrochloride 10 MG Oral TabletSCD83b19193-4db1-4365-a110-e8c67d792c2114
1738495paroxetine hydrochloride 20 MG Oral TabletSCD83b19193-4db1-4365-a110-e8c67d792c2114
1738483PARoxetine HCl 10 MG Oral TabletPSNfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
1738495PARoxetine HCl 20 MG Oral TabletPSNfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
1738483paroxetine hydrochloride 10 MG Oral TabletSCDfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
1738495paroxetine hydrochloride 20 MG Oral TabletSCDfce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b9
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
1738483PARoxetine HCl 10 MG Oral TabletPSNc6ad2450-bda9-4e4e-8bf2-50986a1c8b9f4
1738495PARoxetine HCl 20 MG Oral TabletPSNc6ad2450-bda9-4e4e-8bf2-50986a1c8b9f4
1738483paroxetine hydrochloride 10 MG Oral TabletSCDc6ad2450-bda9-4e4e-8bf2-50986a1c8b9f4
1738495paroxetine hydrochloride 20 MG Oral TabletSCDc6ad2450-bda9-4e4e-8bf2-50986a1c8b9f4
1738483PARoxetine HCl 10 MG Oral TabletPSNb6feadfb-c2a7-4b92-89f0-e130f54ab6322
1738483paroxetine hydrochloride 10 MG Oral TabletSCDb6feadfb-c2a7-4b92-89f0-e130f54ab6322
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
60505-0097-16050500970130 TABLET, FILM COATED in 1 BOTTLE (60505-0097-1) 2003-09-080000-00-00NoNoCurrent
60505-0097-260505009702100 TABLET, FILM COATED in 1 BOTTLE (60505-0097-2) 2003-09-080000-00-00NoNoCurrent
60505-0097-4605050097041000 TABLET, FILM COATED in 1 BOTTLE (60505-0097-4) 2003-09-080000-00-00NoNoCurrent
60505-0097-56050500970510 BLISTER PACK in 1 CARTON (60505-0097-5) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2003-09-080000-00-00NoNoCurrent
60505-0097-76050500970718000 TABLET, FILM COATED in 1 BOTTLE (60505-0097-7) 2003-09-080000-00-00NoNoCurrent
60505-0097-96050500970990 TABLET, FILM COATED in 1 BOTTLE (60505-0097-9) 2003-09-080000-00-00NoNoCurrent