FDA.reportPublic FDA data

Sertraline

Product NDC
71335-2659
11-digit product format
713352659
Labeler code
71335
Product ID
71335-2659_5e3634b1-0d8b-4e23-9dd7-ec4fc3826b65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076465
Marketing category
ANDA
Marketing start
2023-02-23
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
71335-2659-1Sertraline30 in 1 BOTTLETABLET, FILM COATED301
71335-2659-2Sertraline60 in 1 BOTTLETABLET, FILM COATED601
71335-2659-3Sertraline90 in 1 BOTTLETABLET, FILM COATED901
71335-2659-4Sertraline180 in 1 BOTTLETABLET, FILM COATED1801
71335-2659-5Sertraline28 in 1 BOTTLETABLET, FILM COATED281
71335-2659-6Sertraline120 in 1 BOTTLETABLET, FILM COATED1201
71335-2659-7Sertraline100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2659-1EA - Each71335-26593b1b854c-33ef-4a8b-b248-41e2b859321c12026-04-20
71335-2659-2EA - Each71335-2659ffa3c087-d382-4d9d-9003-fb7a0162aebb12026-04-20
71335-2659-3EA - Each71335-2659fcc0463d-e734-4652-8ba9-1cb4888579fb12026-04-20
71335-2659-4EA - Each71335-2659a4df8748-36dd-4618-88b7-abf214d0d4ba12026-04-20
71335-2659-5EA - Each71335-265973a3675d-8fdc-424a-9da2-1983f766a94812026-04-20
71335-2659-6EA - Each71335-26594d613c1f-393a-49fe-94c3-eedd10666bdc12026-04-20
71335-2659-7EA - Each71335-2659c79d4bdd-d1c1-4b1e-a245-b9efbd125b7f12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNc67bc43d-d341-47c6-8b81-a7ad4cdb12071
312940sertraline 25 MG Oral TabletSCDc67bc43d-d341-47c6-8b81-a7ad4cdb12071
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYc67bc43d-d341-47c6-8b81-a7ad4cdb12071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2659-17133526590130 TABLET, FILM COATED in 1 BOTTLE (71335-2659-1) 2025-06-23NoNoHistorical
71335-2659-27133526590260 TABLET, FILM COATED in 1 BOTTLE (71335-2659-2) 2025-06-23NoNoHistorical
71335-2659-37133526590390 TABLET, FILM COATED in 1 BOTTLE (71335-2659-3) 2025-06-23NoNoHistorical
71335-2659-471335265904180 TABLET, FILM COATED in 1 BOTTLE (71335-2659-4) 2025-06-23NoNoHistorical
71335-2659-57133526590528 TABLET, FILM COATED in 1 BOTTLE (71335-2659-5) 2025-06-23NoNoHistorical
71335-2659-671335265906120 TABLET, FILM COATED in 1 BOTTLE (71335-2659-6) 2025-06-23NoNoHistorical
71335-2659-771335265907100 TABLET, FILM COATED in 1 BOTTLE (71335-2659-7) 2025-06-23NoNoHistorical