Paroxetine

Product NDC
50090-0921
11-digit product format
500900921
Labeler code
50090
Product ID
50090-0921_8da2d290-c9b4-4c47-803d-521022a3a122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078406
Marketing category
ANDA
Marketing start
2009-12-03
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
50090-0921-02020-01-31C16284748780-19d75b9d0-33e8-f424-e053-dadaa90a57ceParoxetine Tablets, USP
50090-0921-12020-01-31C16284748780-19d75b9d0-33e8-f424-e053-dadaa90a57ceParoxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0921-0Paroxetine30 in 1 BOTTLETABLET, FILM COATED302
50090-0921-1Paroxetine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0921-0EA - Each50090-092129f2dab3-f2e9-4eac-9703-a74a9959d8e512018-10-11
50090-0921-1EA - Each50090-09213c17f3ee-afc3-4f35-ba0a-c7c54a6e041212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0921PAROXETINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20171031_f7aed6f5-da6c-438c-99d7-ccb346d257f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSNf7aed6f5-da6c-438c-99d7-ccb346d257f52
1738511paroxetine hydrochloride 40 MG Oral TabletSCDf7aed6f5-da6c-438c-99d7-ccb346d257f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0921-05009009210030 in 1 BOTTLEHistorical
50090-0921-15009009210190 in 1 BOTTLEHistorical