FDA.reportPublic FDA data

Sertraline

Product NDC
72162-2411
11-digit product format
721622411
Labeler code
72162
Product ID
72162-2411_f2da9a9d-f2dd-474e-a81e-dfbecd4d78b9
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
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938

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
72162-2411-0Sertraline1000 in 1 BOTTLETABLET, FILM COATED1000103
72162-2411-1Sertraline100 in 1 BOTTLETABLET, FILM COATED100103
72162-2411-5Sertraline500 in 1 BOTTLETABLET, FILM COATED500103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2411-0EA - Each72162-24112aa8db88-7012-4f3a-8f1d-3b32b742f3d412024-12-10
72162-2411-1EA - Each72162-241134d18099-5624-4e8f-be11-81110c38350e12024-12-10
72162-2411-5EA - Each72162-24111e292f14-7bd2-47d3-a2ad-7b0b04fe7d8e12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2411SERTRALINE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 3 package rows20250330_e0adb991-ec4e-4cd1-b54e-6d8c731a1d59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNe0adb991-ec4e-4cd1-b54e-6d8c731a1d59103
312938sertraline 100 MG Oral TabletSCDe0adb991-ec4e-4cd1-b54e-6d8c731a1d59103
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYe0adb991-ec4e-4cd1-b54e-6d8c731a1d59103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2411-0721622411001000 TABLET, FILM COATED in 1 BOTTLE (72162-2411-0) 2024-10-30NoNoHistorical
72162-2411-172162241101100 TABLET, FILM COATED in 1 BOTTLE (72162-2411-1) 2024-10-30NoNoHistorical
72162-2411-572162241105500 TABLET, FILM COATED in 1 BOTTLE (72162-2411-5) 2024-10-30NoNoHistorical