FDA.reportPublic FDA data

Paroxetine

Product NDC
63629-1840
11-digit product format
636291840
Labeler code
63629
Product ID
63629-1840_f413f31d-a9e9-44db-a6b5-6bde77742238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
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
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 HEMIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738495

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1840-12021-12-28C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-22021-12-28C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-32021-12-28C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-42021-12-28C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-12020-01-31C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-22020-01-31C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-32020-01-31C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
63629-1840-42020-01-31C16284748780-19d75b9d0-3286-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1840-1Paroxetine30 in 1 BOTTLETABLET, FILM COATED308
63629-1840-2Paroxetine60 in 1 BOTTLETABLET, FILM COATED608
63629-1840-3Paroxetine28 in 1 BOTTLETABLET, FILM COATED288
63629-1840-4Paroxetine90 in 1 BOTTLETABLET, FILM COATED908
63629-1840-5Paroxetine180 in 1 BOTTLETABLET, FILM COATED1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1840-1EA - Each63629-1840c9e9d7d2-b3d0-4b80-832c-d54d96c36eb512012-07-24
63629-1840-2EA - Each63629-184084aca7cd-7041-42cb-91bc-90f49bcb8d3c12012-07-24
63629-1840-3EA - Each63629-1840c9857f11-2bfd-409e-a087-24de3fdf70c712023-02-06
63629-1840-4EA - Each63629-1840fdadde89-8836-4e6c-a618-2a65e1389d1712023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1840PAROXETINE TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 5 package rows20240830_40dcf270-64bb-bca0-db08-6b233a3430f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN40dcf270-64bb-bca0-db08-6b233a3430f88
1738495paroxetine hydrochloride 20 MG Oral TabletSCD40dcf270-64bb-bca0-db08-6b233a3430f88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1840-16362918400130 TABLET, FILM COATED in 1 BOTTLE (63629-1840-1) 2023-03-010000-00-00NoNoCurrent
63629-1840-26362918400260 TABLET, FILM COATED in 1 BOTTLE (63629-1840-2) 2008-10-100000-00-00NoNoCurrent
63629-1840-36362918400328 TABLET, FILM COATED in 1 BOTTLE (63629-1840-3) 2010-03-040000-00-00NoNoCurrent
63629-1840-46362918400490 TABLET, FILM COATED in 1 BOTTLE (63629-1840-4) 2010-03-230000-00-00NoNoCurrent
63629-1840-563629184005180 TABLET, FILM COATED in 1 BOTTLE (63629-1840-5) 2023-03-010000-00-00NoNoCurrent