FDA.reportPublic FDA data

Sertraline

Product NDC
50090-0989
11-digit product format
500900989
Labeler code
50090
Product ID
50090-0989_9a579859-c6cb-4ba3-8b1f-3279c0a861c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
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
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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312941

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
50090-0989-02023-02-07C16284748780-1f386c64a-41aa-0266-e053-dadaa90a7c1aThese 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
50090-0989-12023-02-07C16284748780-1f386c64a-41aa-0266-e053-dadaa90a7c1aThese 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
50090-0989-22023-02-07C16284748780-1f386c64a-41aa-0266-e053-dadaa90a7c1aThese 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
50090-0989-02023-01-30C16284748780-1f386c64a-41aa-0266-e053-dadaa90a7c1aThese 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
50090-0989-12023-01-30C16284748780-1f386c64a-41aa-0266-e053-dadaa90a7c1aThese 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
50090-0989-22023-01-30C16284748780-1f386c64a-41aa-0266-e053-dadaa90a7c1aThese 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
50090-0989-0Sertraline30 in 1 BOTTLETABLET, FILM COATED308
50090-0989-1Sertraline60 in 1 BOTTLETABLET, FILM COATED608
50090-0989-2Sertraline90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0989-0EA - Each50090-0989417fd318-cfbd-4983-b8af-3c0b9135f68012022-12-07
50090-0989-1EA - Each50090-0989777fbb5d-5ca1-4861-b333-81b29fcb73ae12022-12-07
50090-0989-2EA - Each50090-0989a060fdd1-85f7-43c2-8916-08441099110212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0989SERTRALINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20230208_7b5c29ff-25c8-4b68-844d-b8e95be7d09b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN7b5c29ff-25c8-4b68-844d-b8e95be7d09b8
312941sertraline 50 MG Oral TabletSCD7b5c29ff-25c8-4b68-844d-b8e95be7d09b8
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY7b5c29ff-25c8-4b68-844d-b8e95be7d09b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0989-05009009890030 TABLET, FILM COATED in 1 BOTTLE (50090-0989-0) 2014-11-280000-00-00NoNoCurrent
50090-0989-15009009890160 TABLET, FILM COATED in 1 BOTTLE (50090-0989-1) 2014-11-280000-00-00NoNoCurrent
50090-0989-25009009890290 TABLET, FILM COATED in 1 BOTTLE (50090-0989-2) 2014-11-280000-00-00NoNoCurrent