SERTRALINE HYDROCHLORIDE

Product NDC
61919-014
11-digit product format
619190014
Labeler code
61919
Product ID
61919-014_9cad1e5b-ed06-5c9a-e053-2995a90ac9ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077206
Marketing category
ANDA
Marketing start
2017-02-14
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

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
61919-014-602023-01-30C16284748780-1f386c649-b04c-0266-e053-dadaa90a7c1aSERTRALINE HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-014-60SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-014-60EA - Each61919-014bb74b5e6-ba4f-4582-9bb0-1821f1a85e0a12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-014SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20200130_4883ccdf-0e02-579d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN4883ccdf-0e02-579d-e054-00144ff88e882
312941sertraline 50 MG Oral TabletSCD4883ccdf-0e02-579d-e054-00144ff88e882
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4883ccdf-0e02-579d-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-014-606191900146060 TABLET, FILM COATED in 1 BOTTLE (61919-014-60) 2017-02-140000-00-00NoNoCurrent