Sertraline

Product NDC
50090-7230
11-digit product format
500907230
Labeler code
50090
Product ID
50090-7230_0e635a5b-80d0-434b-8541-22419988bc7f
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7230-0Sertraline90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7230-0EA - Each50090-723086566d59-25c0-4c0b-a19f-169811792b5d12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7230SERTRALINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, 1 package rows20241025_e93391c9-db88-4fa5-b1d5-f6c6de78b31c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNe93391c9-db88-4fa5-b1d5-f6c6de78b31c11
312940sertraline 25 MG Oral TabletSCDe93391c9-db88-4fa5-b1d5-f6c6de78b31c11
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYe93391c9-db88-4fa5-b1d5-f6c6de78b31c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7230-05009072300090 TABLET, FILM COATED in 1 BOTTLE (50090-7230-0) 2024-08-23NoNoCurrent