Sertraline

Product NDC
67046-668
11-digit product format
670460668
Labeler code
67046
Product ID
67046-668_7e2b672c-70b4-8ef1-e053-2991aa0a1af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-668-30Sertraline30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-668SERTRALINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 1 package rows20181230_597bab7a-3ba0-1083-e053-2a91aa0a9d48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN597bab7a-3ba0-1083-e053-2a91aa0a9d482
312938sertraline 100 MG Oral TabletSCD597bab7a-3ba0-1083-e053-2a91aa0a9d482
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY597bab7a-3ba0-1083-e053-2a91aa0a9d482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-668-306704606683030 TABLET, FILM COATED in 1 BLISTER PACK (67046-668-30) 2017-09-180000-00-00NoNoCurrent