FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50090-7661
11-digit product format
500907661
Labeler code
50090
Product ID
50090-7661_66ca5c23-a5b3-49eb-8f17-ef7ab9dec544
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077670
Marketing category
ANDA
Marketing start
2025-08-06
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
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 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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7661-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
50090-7661-1Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6011
50090-7661-2Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7661-0EA - Each50090-76611864a33d-0704-4112-90cb-35ea7f99316312025-12-16
50090-7661-1EA - Each50090-76617109197e-cb65-43a4-a260-0c99cf3b8ba012025-12-16
50090-7661-2EA - Each50090-7661a8c6b4fe-d95d-473e-9b53-ea338bb1173b12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSNb5e98b93-d8f8-4eed-8a0a-63b347b670ed11
312941sertraline 50 MG Oral TabletSCDb5e98b93-d8f8-4eed-8a0a-63b347b670ed11
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYb5e98b93-d8f8-4eed-8a0a-63b347b670ed11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7661-05009076610030 TABLET, FILM COATED in 1 BOTTLE (50090-7661-0) 2025-09-29NoNoHistorical
50090-7661-15009076610160 TABLET, FILM COATED in 1 BOTTLE (50090-7661-1) 2025-09-29NoNoHistorical
50090-7661-25009076610290 TABLET, FILM COATED in 1 BOTTLE (50090-7661-2) 2025-09-29NoNoHistorical