FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68071-4658
11-digit product format
680714658
Labeler code
68071
Product ID
68071-4658_1ab8623f-199b-3196-e063-6294a90a50c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
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 Hydrochloride
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
68071-4658-32024-06-12C16284748780-1ba0f9c33-2785-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
68071-4658-32023-01-30C16284748780-1ba0f9c33-2785-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
68071-4658-32021-02-17C16284748780-1ba0f9c33-2785-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
68071-4658-32021-01-29C16284748780-1ba0f9c33-2785-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4658-3Sertraline Hydrochloride30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4658SERTRALINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240614_7cadc747-5606-8efe-e053-2991aa0a1d8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN7cadc747-5606-8efe-e053-2991aa0a1d8f4
312938sertraline 100 MG Oral TabletSCD7cadc747-5606-8efe-e053-2991aa0a1d8f4
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY7cadc747-5606-8efe-e053-2991aa0a1d8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4658-36807146580330 TABLET in 1 BOTTLE (68071-4658-3) 30 tablet2018-12-100000-00-00NoNoCurrent