FDA.reportPublic FDA data

Paroxetine

Product NDC
0378-7001
11-digit product format
003787001
Labeler code
0378
Product ID
0378-7001_3e4bd491-25fa-466f-b653-f36241ffde16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078902
Marketing category
ANDA
Marketing start
2008-03-24
Substance
PAROXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
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
0378-7001-10Paroxetine1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100020
0378-7001-93Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7001-10EA - Each0378-7001816e1638-032d-426c-81d8-ab2efdef9dde12012-07-24
0378-7001-93EA - Each0378-700186d540e3-f73a-4f11-a040-b528e83507a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
TRIACETININACTIVE INGREDIENTXHX3C3X673PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]9
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7001PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 2 package rows20250425_89dd7e24-85fc-4152-89ea-47ec2b48a1ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNff7c7e20-c9ee-4693-beaa-7ac532d5c4b724
1738483paroxetine hydrochloride 10 MG Oral TabletSCDff7c7e20-c9ee-4693-beaa-7ac532d5c4b724
1738483PARoxetine HCl 10 MG Oral TabletPSN89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738495PARoxetine HCl 20 MG Oral TabletPSN89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738503PARoxetine HCl 30 MG Oral TabletPSN89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738511PARoxetine HCl 40 MG Oral TabletPSN89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738483paroxetine hydrochloride 10 MG Oral TabletSCD89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738495paroxetine hydrochloride 20 MG Oral TabletSCD89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738503paroxetine hydrochloride 30 MG Oral TabletSCD89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738511paroxetine hydrochloride 40 MG Oral TabletSCD89dd7e24-85fc-4152-89ea-47ec2b48a1ed20
1738483PARoxetine HCl 10 MG Oral TabletPSN0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738495PARoxetine HCl 20 MG Oral TabletPSN0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738503PARoxetine HCl 30 MG Oral TabletPSN0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738511PARoxetine HCl 40 MG Oral TabletPSN0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738483paroxetine hydrochloride 10 MG Oral TabletSCD0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738495paroxetine hydrochloride 20 MG Oral TabletSCD0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738503paroxetine hydrochloride 30 MG Oral TabletSCD0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738511paroxetine hydrochloride 40 MG Oral TabletSCD0fb2e3cc-b9b5-48a6-b487-1e558dfd56db2
1738483PARoxetine HCl 10 MG Oral TabletPSN2eebd2b6-7c64-45ca-8eb5-5201137f610a1
1738483paroxetine hydrochloride 10 MG Oral TabletSCD2eebd2b6-7c64-45ca-8eb5-5201137f610a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-7001-10003787001101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10) 2008-03-240000-00-00NoNoCurrent
0378-7001-930037870019330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93) 2008-03-240000-00-00NoNoCurrent