FDA.reportPublic FDA data

Paroxetine

Product NDC
50090-1297
11-digit product format
500901297
Labeler code
50090
Product ID
50090-1297_539e7ed9-6526-4b0f-be3c-eb212d39c653
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Substance
PAROXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1297-0Paroxetine90 in 1 BOTTLETABLET, FILM COATED908
50090-1297-1Paroxetine30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1297PAROXETINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, 2 package rows20241016_31e4bb7c-59ab-4cbf-ba08-317c1417b28f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN31e4bb7c-59ab-4cbf-ba08-317c1417b28f8
1738483paroxetine hydrochloride 10 MG Oral TabletSCD31e4bb7c-59ab-4cbf-ba08-317c1417b28f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1297-05009012970090 TABLET, FILM COATED in 1 BOTTLE (50090-1297-0) 2014-11-28NoNoCurrent
50090-1297-15009012970130 TABLET, FILM COATED in 1 BOTTLE (50090-1297-1) 2014-11-28NoNoCurrent