FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
0615-8604
11-digit product format
006158604
Labeler code
0615
Product ID
0615-8604_339cfb58-17b5-460a-a7bb-fd5334fbc148
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077670
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2027-12-31

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
0615-8604-05Sertraline Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED152
0615-8604-28Sertraline Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED282
0615-8604-39Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline HCl 25 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline HCl 50 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline 100 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline 25 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline 50 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8604-050061586040515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8604-05) 2025-11-19NoNoHistorical
0615-8604-280061586042828 TABLET, FILM COATED in 1 BLISTER PACK (0615-8604-28) 2025-11-19NoNoHistorical
0615-8604-390061586043930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8604-39) 2025-11-19NoNoHistorical