FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-0808
11-digit product format
713350808
Labeler code
71335
Product ID
71335-0808_5c6c817e-a555-4f55-837d-94458787fcb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077206
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 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
71335-0808-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-0808-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-0808-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102
71335-0808-4Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180102
71335-0808-5Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28102
71335-0808-6Sertraline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0808-1EA - Each71335-080886781c3e-b52c-4af1-a2d7-c5429950322e12020-07-13
71335-0808-3EA - Each71335-08088ba09db6-f0d0-4f99-a086-c5e60eacef2812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0808SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240530_5c6c817e-a555-4f55-837d-94458787fcb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN5c6c817e-a555-4f55-837d-94458787fcb6102
312940sertraline 25 MG Oral TabletSCD5c6c817e-a555-4f55-837d-94458787fcb6102
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY5c6c817e-a555-4f55-837d-94458787fcb6102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0808-17133508080130 TABLET, FILM COATED in 1 BOTTLE (71335-0808-1) 2018-06-250000-00-00NoNoCurrent
71335-0808-27133508080260 TABLET, FILM COATED in 1 BOTTLE (71335-0808-2) 2018-05-030000-00-00NoNoCurrent
71335-0808-37133508080390 TABLET, FILM COATED in 1 BOTTLE (71335-0808-3) 2018-05-160000-00-00NoNoCurrent
71335-0808-471335080804180 TABLET, FILM COATED in 1 BOTTLE (71335-0808-4) 2024-05-220000-00-00NoNoCurrent
71335-0808-57133508080528 TABLET, FILM COATED in 1 BOTTLE (71335-0808-5) 2024-05-220000-00-00NoNoCurrent
71335-0808-671335080806120 TABLET, FILM COATED in 1 BOTTLE (71335-0808-6) 2023-11-080000-00-00NoNoCurrent