Paroxetine

Product NDC
33261-090
11-digit product format
332610090
Labeler code
33261
Product ID
33261-090_847c3a3f-7716-462c-a7f3-481e3501876b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
10 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
33261-090-302020-01-31C16284748780-19d75b9d0-a264-f424-e053-dadaa90a57ceParoxetine Tablets, USP
33261-090-602020-01-31C16284748780-19d75b9d0-a264-f424-e053-dadaa90a57ceParoxetine Tablets, USP
33261-090-902020-01-31C16284748780-19d75b9d0-a264-f424-e053-dadaa90a57ceParoxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-090-30Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
33261-090-60Paroxetine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
33261-090-90Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-090-30EA - Each33261-090e951edd5-fbee-4120-ac81-a127bfc63e2f12014-02-04
33261-090-60EA - Each33261-0903f2d0433-3401-45b7-a887-73a9840a9ff012014-02-04
33261-090-90EA - Each33261-0901c6dc95c-b7eb-491b-86a9-5cc723ff320012014-02-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-090PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_a03e69aa-3d6f-42fd-9cd1-9c1399bb5fa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNa03e69aa-3d6f-42fd-9cd1-9c1399bb5fa51
1738495PARoxetine HCl 20 MG Oral TabletPSNa03e69aa-3d6f-42fd-9cd1-9c1399bb5fa51
1738483paroxetine hydrochloride 10 MG Oral TabletSCDa03e69aa-3d6f-42fd-9cd1-9c1399bb5fa51
1738495paroxetine hydrochloride 20 MG Oral TabletSCDa03e69aa-3d6f-42fd-9cd1-9c1399bb5fa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-090-303326100903030 in 1 BOTTLE, PLASTICHistorical
33261-090-603326100906060 in 1 BOTTLE, PLASTICHistorical
33261-090-903326100909090 in 1 BOTTLE, PLASTICHistorical