FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
72789-092
11-digit product format
727890092
Labeler code
72789
Product ID
72789-092_2bacb39d-8830-016c-e063-6394a90a62ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
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 Hydrochloride
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
72789-092-30Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3029
72789-092-60Sertraline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6029
72789-092-90Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-092-90EA - Each72789-092e30b2781-ede4-4be8-a94e-40bc98ffda4112020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-092SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]29Current NDC, Legacy NDC, 3 package rows20250115_c4bad433-623b-402c-b454-d39f19a23627.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNc4bad433-623b-402c-b454-d39f19a2362729
312938sertraline 100 MG Oral TabletSCDc4bad433-623b-402c-b454-d39f19a2362729
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc4bad433-623b-402c-b454-d39f19a2362729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-092-307278900923030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-30) 2020-08-140000-00-00NoNoCurrent
72789-092-607278900926060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-60) 2020-09-300000-00-00NoNoCurrent
72789-092-907278900929090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-092-90) 2020-06-220000-00-00NoNoCurrent