FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
72162-2370
11-digit product format
721622370
Labeler code
72162
Product ID
72162-2370_d1674477-7cd3-4fa1-bfa3-7093e0170c2b
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
72162-2370-1Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100101
72162-2370-3Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30101
72162-2370-6Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60101
72162-2370-8Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180101
72162-2370-9Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2370-1EA - Each72162-23705bf5c608-b185-4022-ab50-0d40ce9c15ad12024-08-12
72162-2370-3EA - Each72162-2370bbba91b7-fb15-47f6-8c5d-96f643fd19f712024-12-10
72162-2370-6EA - Each72162-237054fccf98-2717-44c1-b53a-93f028ed2bba12024-12-10
72162-2370-8EA - Each72162-2370dbf36609-f227-4559-99d1-e11d35be6f0812024-12-10
72162-2370-9EA - Each72162-2370a2a1e41b-74d3-4600-81aa-3b58ebcc920512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2370SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 5 package rows20241020_4191b929-5bdb-4388-9e4d-fffce55bc363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN4191b929-5bdb-4388-9e4d-fffce55bc363101
312941sertraline 50 MG Oral TabletSCD4191b929-5bdb-4388-9e4d-fffce55bc363101
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4191b929-5bdb-4388-9e4d-fffce55bc363101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2370-172162237001100 TABLET, FILM COATED in 1 BOTTLE (72162-2370-1) 2024-07-16NoNoHistorical
72162-2370-37216223700330 TABLET, FILM COATED in 1 BOTTLE (72162-2370-3) 2024-07-16NoNoHistorical
72162-2370-67216223700660 TABLET, FILM COATED in 1 BOTTLE (72162-2370-6) 2024-07-16NoNoHistorical
72162-2370-872162237008180 TABLET, FILM COATED in 1 BOTTLE (72162-2370-8) 2024-07-16NoNoHistorical
72162-2370-97216223700990 TABLET, FILM COATED in 1 BOTTLE (72162-2370-9) 2024-07-16NoNoHistorical