Sertraline Hydrochloride

Product NDC
58118-0834
11-digit product format
581180834
Labeler code
58118
Product ID
58118-0834_b001e3e8-7f6d-3dfd-e053-2995a90a87b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 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
58118-0834-82024-01-30C16284748780-11030e365-2a6a-111a-e063-dadaa90a10e27a3d3767-a658-4430-ac26-0d94e32dd8aa

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0834SERTRALINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]6Legacy NDC20200924_7a3d3767-a658-4430-ac26-0d94e32dd8aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0834-85811808340830 TABLET in 1 BLISTER PACK (58118-0834-8) 30 tablet2017-02-070000-00-00NoNoCurrent