Paroxetine

Product NDC
58118-0183
11-digit product format
581180183
Labeler code
58118
Product ID
58118-0183_b0262e43-596b-12cc-e053-2995a90ae785
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0183-82024-01-30C16284748780-11030e365-1f1f-111a-e063-dadaa90a10e24a713dae-d04b-4e26-aa22-d803e49c1b90

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0183PAROXETINE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]6Legacy NDC20200926_4a713dae-d04b-4e26-aa22-d803e49c1b90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0183-85811801830830 TABLET, FILM COATED in 1 BLISTER PACK (58118-0183-8) 2017-01-040000-00-00NoNoCurrent