FDA.reportPublic FDA data

Paroxetine

Product NDC
50436-3933
11-digit product format
504363933
Labeler code
50436
Product ID
50436-3933_3c32f960-ac0d-461c-9d73-2110b36291b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
50436-3933-32021-01-29C16284748780-1ba0f9c33-5585-a910-e053-dadaa90a0b85Paroxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3933-3Paroxetine90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3933-3EA - Each50436-3933ee593e43-718c-493a-aed7-5bbf1fb8d6b612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3933PAROXETINE TABLET, FILM COATED [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20171109_4847a2ec-e72b-48b0-a7c7-685fff62b1d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN4847a2ec-e72b-48b0-a7c7-685fff62b1d96
1738495paroxetine hydrochloride 20 MG Oral TabletSCD4847a2ec-e72b-48b0-a7c7-685fff62b1d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3933-35043639330390 in 1 BOTTLEHistorical