FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
43602-980
11-digit product format
436020980
Labeler code
43602
Product ID
43602-980_91447af3-b3d6-4ffe-8c89-1869a22373ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ascent Pharmaceuticals, Inc.
Application
ANDA214790
Marketing category
ANDA
Marketing start
2021-05-03
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 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
43602-980-15SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET301
43602-980-16SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43602-980SERTRALINE HYDROCHLORIDE TABLET [ASCENT PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20210803_056191ca-999a-4c9b-93b9-64db44b8e628.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN056191ca-999a-4c9b-93b9-64db44b8e6281
312940sertraline HCl 25 MG Oral TabletPSN056191ca-999a-4c9b-93b9-64db44b8e6281
312941sertraline HCl 50 MG Oral TabletPSN056191ca-999a-4c9b-93b9-64db44b8e6281
312938sertraline 100 MG Oral TabletSCD056191ca-999a-4c9b-93b9-64db44b8e6281
312940sertraline 25 MG Oral TabletSCD056191ca-999a-4c9b-93b9-64db44b8e6281
312941sertraline 50 MG Oral TabletSCD056191ca-999a-4c9b-93b9-64db44b8e6281
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY056191ca-999a-4c9b-93b9-64db44b8e6281
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY056191ca-999a-4c9b-93b9-64db44b8e6281
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY056191ca-999a-4c9b-93b9-64db44b8e6281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43602-980-154360209801530 TABLET in 1 BOTTLE (43602-980-15) 30 tablet2021-05-030000-00-00NoNoCurrent
43602-980-1643602098016500 TABLET in 1 BOTTLE (43602-980-16) 500 tablet2021-05-030000-00-00NoNoCurrent