FDA.reportPublic FDA data

Sertraline

Product NDC
50090-5848
11-digit product format
500905848
Labeler code
50090
Product ID
50090-5848_c029a9c5-86c9-43d2-831c-6b9fe1443094
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
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312940

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
50090-5848-02023-02-07C16284748780-1f386c649-f2b1-0266-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
50090-5848-12023-02-07C16284748780-1f386c649-f2b1-0266-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
50090-5848-02023-01-30C16284748780-1f386c649-f2b1-0266-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
50090-5848-12023-01-30C16284748780-1f386c649-f2b1-0266-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
50090-5848-0Sertraline30 in 1 BOTTLETABLET, FILM COATED3015
50090-5848-1Sertraline90 in 1 BOTTLETABLET, FILM COATED9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5848-0EA - Each50090-58484260be46-5b4d-4b41-8304-a71f03a519ef12022-06-06
50090-5848-1EA - Each50090-5848f220cfd2-5eb3-4340-b3b7-ea6a5c4081ee12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5848SERTRALINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20240830_cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNcbc2bd3b-03fc-47b9-91d1-8989ec90c7e615
312940sertraline 25 MG Oral TabletSCDcbc2bd3b-03fc-47b9-91d1-8989ec90c7e615
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYcbc2bd3b-03fc-47b9-91d1-8989ec90c7e615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5848-05009058480030 TABLET, FILM COATED in 1 BOTTLE (50090-5848-0) 2021-11-050000-00-00NoNoCurrent
50090-5848-15009058480190 TABLET, FILM COATED in 1 BOTTLE (50090-5848-1) 2021-11-050000-00-00NoNoCurrent