FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50090-6379
11-digit product format
500906379
Labeler code
50090
Product ID
50090-6379_024c0025-c427-4f09-87d9-07b6a92e43a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077206
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 Hydrochloride
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6379-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
50090-6379-1Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
50090-6379-2Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6379SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230301_513ecb5b-062f-455f-b798-1c9a54222ff3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN513ecb5b-062f-455f-b798-1c9a54222ff31
312941sertraline 50 MG Oral TabletSCD513ecb5b-062f-455f-b798-1c9a54222ff31
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY513ecb5b-062f-455f-b798-1c9a54222ff31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6379-05009063790030 TABLET, FILM COATED in 1 BOTTLE (50090-6379-0) 2023-02-23NoNoCurrent
50090-6379-15009063790160 TABLET, FILM COATED in 1 BOTTLE (50090-6379-1) 2023-02-23NoNoCurrent
50090-6379-25009063790290 TABLET, FILM COATED in 1 BOTTLE (50090-6379-2) 2023-02-23NoNoCurrent