SERTRALINE HYDROCHLORIDE

Product NDC
67046-665
11-digit product format
670460665
Labeler code
67046
Product ID
67046-665_3e2cb0ae-2284-44d0-9eff-f7d4ab6501a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA019839
Marketing category
NDA
Marketing start
2010-03-15
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-665-302019-10-21C16284748780-1956f9ecf-d9f5-621f-e053-dbdaa90a74adSERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-665-30SERTRALINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-665SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100322_3e2cb0ae-2284-44d0-9eff-f7d4ab6501a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN3e2cb0ae-2284-44d0-9eff-f7d4ab6501a51
312938sertraline 100 MG Oral TabletSCD3e2cb0ae-2284-44d0-9eff-f7d4ab6501a51
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY3e2cb0ae-2284-44d0-9eff-f7d4ab6501a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-665-306704606653030 in 1 BLISTER PACKHistorical