FDA.reportPublic FDA data

Sertraline

Product NDC
23155-759
11-digit product format
231550759
Labeler code
23155
Product ID
23155-759_5079a5d2-af51-4bac-aaad-75653da2aa97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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, 312940, 312941

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
23155-759-03Sertraline30 in 1 BOTTLETABLET, FILM COATED305
23155-759-05Sertraline500 in 1 BOTTLETABLET, FILM COATED5005
23155-759-09Sertraline90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-759-03EA - Each23155-759158797a1-ee0f-4113-a2f2-d3e39b2b56ee12024-01-04
23155-759-05EA - Each23155-759c8988de0-2859-43a8-a365-47f961ab21b112024-01-04
23155-759-09EA - Each23155-7598f2e5220-cfe5-40f3-8778-12f6711a990612024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-759SERTRALINE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 3 package rows20240805_444ca054-e450-4c10-a31b-71ad43946cb8.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
312938sertraline HCl 100 MG Oral TabletPSN444ca054-e450-4c10-a31b-71ad43946cb85
312940sertraline HCl 25 MG Oral TabletPSN444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline HCl 50 MG Oral TabletPSN444ca054-e450-4c10-a31b-71ad43946cb85
312938sertraline 100 MG Oral TabletSCD444ca054-e450-4c10-a31b-71ad43946cb85
312940sertraline 25 MG Oral TabletSCD444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline 50 MG Oral TabletSCD444ca054-e450-4c10-a31b-71ad43946cb85
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY444ca054-e450-4c10-a31b-71ad43946cb85
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY444ca054-e450-4c10-a31b-71ad43946cb85
312938sertraline HCl 100 MG Oral TabletPSN03e1f274-fa9a-4461-b7c9-31ba6428c1071
312938sertraline 100 MG Oral TabletSCD03e1f274-fa9a-4461-b7c9-31ba6428c1071
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY03e1f274-fa9a-4461-b7c9-31ba6428c1071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-759-032315507590330 TABLET, FILM COATED in 1 BOTTLE (23155-759-03) 2023-02-23NoNoCurrent
23155-759-0523155075905500 TABLET, FILM COATED in 1 BOTTLE (23155-759-05) 2023-03-23NoNoCurrent
23155-759-092315507590990 TABLET, FILM COATED in 1 BOTTLE (23155-759-09) 2023-02-23NoNoCurrent