FDA.reportPublic FDA data

Sertraline hydrochloride

Product NDC
71335-2587
11-digit product format
713352587
Labeler code
71335
Product ID
71335-2587_ff5e2ec3-86b9-4cd1-928b-cea8b012c68f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078403
Marketing category
ANDA
Marketing start
2023-05-15
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 hydrochloride
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
71335-2587-1Sertraline hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71335-2587-2Sertraline hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71335-2587-3Sertraline hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
71335-2587-4Sertraline hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
71335-2587-5Sertraline hydrochloride28 in 1 BOTTLETABLET, FILM COATED281
71335-2587-6Sertraline hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
71335-2587-7Sertraline hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2587-1EA - Each71335-2587ad8b450a-d38c-40ee-91a9-e28280d36e9112025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2587SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 7 package rows20250410_9c0a7f78-9cac-4e82-b971-f3f9758f8a0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN9c0a7f78-9cac-4e82-b971-f3f9758f8a0c1
312940sertraline 25 MG Oral TabletSCD9c0a7f78-9cac-4e82-b971-f3f9758f8a0c1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY9c0a7f78-9cac-4e82-b971-f3f9758f8a0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2587-17133525870130 TABLET, FILM COATED in 1 BOTTLE (71335-2587-1) 2025-04-07NoNoHistorical
71335-2587-27133525870260 TABLET, FILM COATED in 1 BOTTLE (71335-2587-2) 2025-04-07NoNoHistorical
71335-2587-37133525870390 TABLET, FILM COATED in 1 BOTTLE (71335-2587-3) 2025-04-07NoNoHistorical
71335-2587-471335258704180 TABLET, FILM COATED in 1 BOTTLE (71335-2587-4) 2025-04-07NoNoHistorical
71335-2587-57133525870528 TABLET, FILM COATED in 1 BOTTLE (71335-2587-5) 2025-04-07NoNoHistorical
71335-2587-671335258706120 TABLET, FILM COATED in 1 BOTTLE (71335-2587-6) 2025-04-07NoNoHistorical
71335-2587-771335258707100 TABLET, FILM COATED in 1 BOTTLE (71335-2587-7) 2025-04-07NoNoHistorical