FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
72789-273
11-digit product format
727890273
Labeler code
72789
Product ID
72789-273_40bac53e-393d-b295-e063-6294a90a5b88
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
72789-273-01Sertraline Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-273SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 1 package rows20240426_3ca30f3f-545e-46c5-b56a-73ec48e9647f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN3ca30f3f-545e-46c5-b56a-73ec48e9647f32
312938sertraline 100 MG Oral TabletSCD3ca30f3f-545e-46c5-b56a-73ec48e9647f32
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY3ca30f3f-545e-46c5-b56a-73ec48e9647f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-273-0172789027301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-273-01) 2022-09-200000-00-00NoNoCurrent