Paroxetine

Product NDC
63739-963
11-digit product format
637390963
Labeler code
63739
Product ID
63739-963_e20ee90d-e93d-7c6d-e053-2995a90adbef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-963-102020-07-22C16284748780-1ab0e2407-354b-f274-e053-dbdaa90a647153f2b8e2-6bac-4a47-b0c8-3442149b7710
63739-963-412020-07-22C16284748780-1ab0e2407-354b-f274-e053-dbdaa90a647153f2b8e2-6bac-4a47-b0c8-3442149b7710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-963-10EA - Each63739-963cdb66b83-6d78-44af-84c3-852390f4eb5712015-10-02
63739-963-41EA - Each63739-963f3cba551-c429-43f6-8747-3f1622b36ba012019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-963PAROXETINE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]18Legacy NDC20250308_53f2b8e2-6bac-4a47-b0c8-3442149b7710.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-963-106373909631010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-963-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-09-090000-00-00NoNoCurrent