FDA.reportPublic FDA data

PAXIL

Product NDC
60505-4378
11-digit product format
605054378
Labeler code
60505
Product ID
60505-4378_57998b73-87c9-7fed-ffa8-7e43620bd98a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp
Application
NDA020936
Marketing category
NDA
Marketing start
2011-01-01
Substance
PAROXETINE HYDROCHLORIDE
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
PAXIL
Brand name suffix
CR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738803, 1738804, 1738805, 1738806, 1738807, 1738808

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
60505-4378-3PAXIL CR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4378-3EA - Each60505-43789e4b9d72-666b-4cd7-a9f4-5f5e9a16747312020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
PAROXETINEACTIVE MOIETY41VRH5220HPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
TALCINACTIVE INGREDIENT7SEV7J4R1UPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4378PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]31Current NDC, Legacy NDC, 1 package rows20240911_483bd97f-c4d0-4e23-aaa8-6334f4471e0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738804PAXIL CR 12.5 MG 24HR Extended Release Oral TabletPSN483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738806PAXIL CR 25 MG 24HR Extended Release Oral TabletPSN483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738808PAXIL CR 37.5 MG 24HR Extended Release Oral TabletPSN483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880424 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet [Paxil]SBD483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880624 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet [Paxil]SBD483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880824 HR paroxetine hydrochloride 37.5 MG Extended Release Oral Tablet [Paxil]SBD483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
173880624 HR Paxil 25 MG Extended Release Oral TabletSY483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738804Paxil 12.5 MG 24 HR Extended Release Oral TabletSY483bd97f-c4d0-4e23-aaa8-6334f4471e0c32
1738808Paxil 37.5 MG 24 HR Extended Release Oral TabletSY483bd97f-c4d0-4e23-aaa8-6334f4471e0c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4378-36050543780330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4378-3) 2011-01-010000-00-00NoNoCurrent