Sertraline

Product NDC
67296-1199
11-digit product format
672961199
Labeler code
67296
Product ID
67296-1199_d610062d-3994-dec3-e053-2995a90a9ca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
67296-1199-92024-01-30C16284748780-11030e365-2ecc-111a-e063-dadaa90a10e24ecc3a7a-972a-2572-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1199-9Sertraline90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1199SERTRALINE TABLET, FILM COATED [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20220121_4ecc3a7a-972a-2572-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN4ecc3a7a-972a-2572-e054-00144ff8d46c5
312941sertraline 50 MG Oral TabletSCD4ecc3a7a-972a-2572-e054-00144ff8d46c5
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4ecc3a7a-972a-2572-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1199-96729611990990 TABLET, FILM COATED in 1 BOTTLE (67296-1199-9) 2007-02-060000-00-00NoNoCurrent