FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
72789-088
11-digit product format
727890088
Labeler code
72789
Product ID
72789-088_4031c5d9-ec99-51f3-e063-6294a90a4bcb
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
72789-088-60Sertraline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-088SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 1 package rows20240331_91b4c802-9c6b-49bb-b5a7-661e1917ef34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN91b4c802-9c6b-49bb-b5a7-661e1917ef3432
312938sertraline 100 MG Oral TabletSCD91b4c802-9c6b-49bb-b5a7-661e1917ef3432
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY91b4c802-9c6b-49bb-b5a7-661e1917ef3432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-088-607278900886060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-088-60) 2020-06-170000-00-00NoNoCurrent