FDA.reportPublic FDA data

Paroxetine

Product NDC
50090-4207
11-digit product format
500904207
Labeler code
50090
Product ID
50090-4207_f530cf4e-06bc-47c3-8781-8fe822106369
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
20 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
50090-4207-02023-01-30C16284748780-1f386c64a-1fc0-0266-e053-dadaa90a7c1aParoxetine Tablets USP, film coated for oral use
50090-4207-12023-01-30C16284748780-1f386c64a-1fc0-0266-e053-dadaa90a7c1aParoxetine Tablets USP, film coated for oral use
50090-4207-22023-01-30C16284748780-1f386c64a-1fc0-0266-e053-dadaa90a7c1aParoxetine Tablets USP, film coated for oral use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4207-0Paroxetine30 in 1 BOTTLETABLET, FILM COATED303
50090-4207-1Paroxetine60 in 1 BOTTLETABLET, FILM COATED603
50090-4207-2Paroxetine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4207PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20210112_fbd967ea-015f-4b8f-a783-293b98ddaa4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSNfbd967ea-015f-4b8f-a783-293b98ddaa4e3
1738495paroxetine hydrochloride 20 MG Oral TabletSCDfbd967ea-015f-4b8f-a783-293b98ddaa4e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4207-05009042070030 TABLET, FILM COATED in 1 BOTTLE (50090-4207-0) 2019-03-220000-00-00NoNoCurrent
50090-4207-15009042070160 TABLET, FILM COATED in 1 BOTTLE (50090-4207-1) 2019-03-220000-00-00NoNoCurrent
50090-4207-25009042070290 TABLET, FILM COATED in 1 BOTTLE (50090-4207-2) 2019-03-220000-00-00NoNoCurrent