FDA.reportPublic FDA data

PAROXETINE

Product NDC
50090-0849
11-digit product format
500900849
Labeler code
50090
Product ID
50090-0849_4c1d0b43-d359-4b13-ab58-7f3b1b109f2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-09-08
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
2022-12-31
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
50090-0849-02023-01-30C16284748780-1f386c649-be9f-0266-e053-dadaa90a7c1aPAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only
50090-0849-12023-01-30C16284748780-1f386c649-be9f-0266-e053-dadaa90a7c1aPAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only
50090-0849-22023-01-30C16284748780-1f386c649-be9f-0266-e053-dadaa90a7c1aPAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0849-0PAROXETINE30 in 1 BOTTLETABLET, FILM COATED3014
50090-0849-1PAROXETINE60 in 1 BOTTLETABLET, FILM COATED6014
50090-0849-2PAROXETINE90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0849-0EA - Each50090-0849275a0c23-fc4c-40c3-a804-427fa251731d12018-10-11
50090-0849-1EA - Each50090-08490ace8a58-c4ce-40b9-9d2e-34dcc79a604712018-10-11
50090-0849-2EA - Each50090-08497b85a8b4-b9d5-4f14-b321-9144d0b9a49212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0849PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Legacy NDC, 3 package rows20210611_83b19193-4db1-4365-a110-e8c67d792c21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN83b19193-4db1-4365-a110-e8c67d792c2114
1738495PARoxetine HCl 20 MG Oral TabletPSN83b19193-4db1-4365-a110-e8c67d792c2114
1738483paroxetine hydrochloride 10 MG Oral TabletSCD83b19193-4db1-4365-a110-e8c67d792c2114
1738495paroxetine hydrochloride 20 MG Oral TabletSCD83b19193-4db1-4365-a110-e8c67d792c2114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0849-05009008490030 TABLET, FILM COATED in 1 BOTTLE (50090-0849-0) 2014-11-280000-00-00NoNoCurrent
50090-0849-15009008490160 TABLET, FILM COATED in 1 BOTTLE (50090-0849-1) 2014-11-280000-00-00NoNoCurrent
50090-0849-25009008490290 TABLET, FILM COATED in 1 BOTTLE (50090-0849-2) 2014-11-280000-00-00NoNoCurrent