FDA.reportPublic FDA data

PAROXETINE HYDROCHLORIDE

Product NDC
60505-3673
11-digit product format
605053673
Labeler code
60505
Product ID
60505-3673_89fb3e22-0b65-b37e-0a61-0f7dbdafb8ab
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
2010-09-13
Marketing end
2022-11-30
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
13 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60505-3673-32020-08-25C16284748780-1ab0e2407-31cc-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use Paroxetine HCL CR safely and effectively. See full prescribing information for Paroxetine HCL CR . PAROXETINE HCL CR (paroxetine) extended-release tablets, for oral use Initial U.S. Approval: 1992
60505-3673-32020-07-22C16284748780-1ab0e2407-31cc-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use Paroxetine HCL CR safely and effectively. See full prescribing information for Paroxetine HCL CR . PAROXETINE HCL CR (paroxetine) extended-release tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3673-3PAROXETINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3673-3EA - Each60505-3673b5abd335-2065-4c3e-b5e9-d64d29078d1112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3673PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]17Legacy NDC, 1 package rows20240504_087ff0d3-1761-47ea-a8c1-7c4cb679af97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN087ff0d3-1761-47ea-a8c1-7c4cb679af9718
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD087ff0d3-1761-47ea-a8c1-7c4cb679af9718
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD087ff0d3-1761-47ea-a8c1-7c4cb679af9718
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY087ff0d3-1761-47ea-a8c1-7c4cb679af9718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3673-36050536730330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3673-3) 2010-09-132022-11-30NoNoCurrent