Paroxetine

Product NDC
50090-4838
11-digit product format
500904838
Labeler code
50090
Product ID
50090-4838_14d1750f-9e97-4ba7-9df2-11e6c9a55ede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203854
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
50090-4838-02023-01-30C16284748780-1f386c64a-1c11-0266-e053-dadaa90a7c1aParoxetine Tablets USP, film coated for oral use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4838-0Paroxetine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4838PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20200204_b4dc49cd-3ea0-413b-bf9d-0788f5e1180d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNb4dc49cd-3ea0-413b-bf9d-0788f5e1180d1
1738483paroxetine hydrochloride 10 MG Oral TabletSCDb4dc49cd-3ea0-413b-bf9d-0788f5e1180d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4838-05009048380090 TABLET, FILM COATED in 1 BOTTLE (50090-4838-0) 2020-01-170000-00-00NoNoCurrent