Ondansetron Hydrochloride

Product NDC
58118-7500
11-digit product format
581187500
Labeler code
58118
Product ID
58118-7500_ae6aad06-092e-fa6b-e053-2995a90afd53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA078539
Marketing category
ANDA
Marketing start
2018-12-13
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
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
58118-7500-82024-01-30C16284748780-11030e365-587e-111a-e063-dadaa90a10e271451add-9117-4512-83cd-08f153ce4a2f

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-7500ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]3Legacy NDC20200904_71451add-9117-4512-83cd-08f153ce4a2f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-7500-85811875000830 TABLET, FILM COATED in 1 BLISTER PACK (58118-7500-8) 2018-12-130000-00-00NoNoCurrent