FDA.reportPublic FDA data

Sertraline

Product NDC
68071-3534
11-digit product format
680713534
Labeler code
68071
Product ID
68071-3534_2d3f9552-fe0c-7056-e063-6394a90a19c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938

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
68071-3534-32025-02-03C16284748780-12cef2736-770a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use sertraline hydrochloride tablets safely and effectively. See full prescribing information for sertraline hydrochloride tablets. SERTRALINE hydrochloride tablets, for oral use Initial U.S. Approval: 1991
68071-3534-32025-01-30C16284748780-12cef2736-770a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use sertraline hydrochloride tablets safely and effectively. See full prescribing information for sertraline hydrochloride tablets. SERTRALINE hydrochloride tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3534-3Sertraline30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3534SERTRALINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_0a1f7d44-c339-a4dd-e063-6294a90ac0de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN0a1f7d44-c339-a4dd-e063-6294a90ac0de2
312938sertraline 100 MG Oral TabletSCD0a1f7d44-c339-a4dd-e063-6294a90ac0de2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY0a1f7d44-c339-a4dd-e063-6294a90ac0de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3534-36807135340330 TABLET, FILM COATED in 1 BOTTLE (68071-3534-3) 2023-11-14NoNoHistorical