FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-2300
11-digit product format
713352300
Labeler code
71335
Product ID
71335-2300_09925dce-5452-444a-aabb-a970cf959e9c
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
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
71335-2300-1Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED1000103
71335-2300-2Sertraline Hydrochloride5000 in 1 BOTTLETABLET, FILM COATED5000103
71335-2300-3Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500103
71335-2300-4Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90103
71335-2300-5Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2300-1EA - Each71335-2300f932ed98-09de-47e6-a50f-b9eba12665fc12024-01-04
71335-2300-2EA - Each71335-23001bd65857-1254-4c23-934a-1eb53f5352cb12024-01-04
71335-2300-3EA - Each71335-23002eab2c40-0803-439a-b78e-b30b298667f812024-01-04
71335-2300-4EA - Each71335-230067d1408d-25f5-49d4-958e-23c1c003b67812025-08-11
71335-2300-5EA - Each71335-230006c7466b-3fbb-4d75-afc7-a2cc1e0e6d0212025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2300SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 5 package rows20240602_50d0aef5-ecc7-49b0-964a-53f87058d22a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN50d0aef5-ecc7-49b0-964a-53f87058d22a103
312941sertraline 50 MG Oral TabletSCD50d0aef5-ecc7-49b0-964a-53f87058d22a103
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY50d0aef5-ecc7-49b0-964a-53f87058d22a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2300-1713352300011000 TABLET, FILM COATED in 1 BOTTLE (71335-2300-1) 2024-05-30NoNoHistorical
71335-2300-2713352300025000 TABLET, FILM COATED in 1 BOTTLE (71335-2300-2) 2024-05-30NoNoHistorical
71335-2300-371335230003500 TABLET, FILM COATED in 1 BOTTLE (71335-2300-3) 2024-05-30NoNoHistorical
71335-2300-47133523000490 TABLET, FILM COATED in 1 BOTTLE (71335-2300-4) 2024-05-30NoNoHistorical
71335-2300-57133523000560 TABLET, FILM COATED in 1 BOTTLE (71335-2300-5) 2024-05-30NoNoHistorical