FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
50090-7691
11-digit product format
500907691
Labeler code
50090
Product ID
50090-7691_4d31aaed-75c6-4e00-9a53-6b8ba850dac5
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
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
Rxcui312941

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
50090-7691-0SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET301
50090-7691-1SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET601
50090-7691-2SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7691-0EA - Each50090-76918fec351c-f2fd-41ef-9c34-75106621a24512025-12-16
50090-7691-1EA - Each50090-769174c81a9d-bdf3-4d15-8e99-06845a39b76e12025-12-16
50090-7691-2EA - Each50090-769162d9c3de-d3c1-45a3-acb5-5846f493f1f912025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN2bb3a2d1-76c4-42e6-8553-aa95f263175b1
312941sertraline 50 MG Oral TabletSCD2bb3a2d1-76c4-42e6-8553-aa95f263175b1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY2bb3a2d1-76c4-42e6-8553-aa95f263175b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7691-05009076910030 TABLET in 1 BOTTLE (50090-7691-0) 30 tablet2025-10-10NoNoCurrent
50090-7691-15009076910160 TABLET in 1 BOTTLE (50090-7691-1) 60 tablet2025-10-10NoNoCurrent
50090-7691-25009076910290 TABLET in 1 BOTTLE (50090-7691-2) 90 tablet2025-10-10NoNoCurrent