FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
50090-7693
11-digit product format
500907693
Labeler code
50090
Product ID
50090-7693_5dbdb645-4666-4bd0-a49a-beacb026cd9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214790
Marketing category
ANDA
Marketing start
2021-05-03
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
50090-7693-0SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET301
50090-7693-1SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET601
50090-7693-2SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7693-0EA - Each50090-769384972dc9-e51e-45aa-aeef-3d0fe82fc14112025-12-16
50090-7693-1EA - Each50090-769369893f3c-17dd-4bee-ba4b-d4ecd006922312025-12-16
50090-7693-2EA - Each50090-769363784017-f883-4ac1-9947-7fdab0d4d23c12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNc0cc1b03-ba35-4a2c-be95-2d9b7f4c34991
312938sertraline 100 MG Oral TabletSCDc0cc1b03-ba35-4a2c-be95-2d9b7f4c34991
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc0cc1b03-ba35-4a2c-be95-2d9b7f4c34991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7693-05009076930030 TABLET in 1 BOTTLE (50090-7693-0) 30 tablet2025-10-10NoNoCurrent
50090-7693-15009076930160 TABLET in 1 BOTTLE (50090-7693-1) 60 tablet2025-10-10NoNoCurrent
50090-7693-25009076930290 TABLET in 1 BOTTLE (50090-7693-2) 90 tablet2025-10-10NoNoCurrent