FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50090-7700
11-digit product format
500907700
Labeler code
50090
Product ID
50090-7700_ea0c1eb8-2ad1-48c5-99c4-0b87f34bad22
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
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7700-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309
50090-7700-1Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
50090-7700-2Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7700-0EA - Each50090-77000d293e96-109b-49f0-af77-1fd95690bae012025-12-16
50090-7700-1EA - Each50090-7700a60b8330-d6ba-4e55-9da5-dcbb73f93c1912025-12-16
50090-7700-2EA - Each50090-7700c9eca67f-b08e-4a0b-bc1f-1adcbebf396812025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN473d6055-b811-4ffb-9398-88f50a1521969
312938sertraline 100 MG Oral TabletSCD473d6055-b811-4ffb-9398-88f50a1521969
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY473d6055-b811-4ffb-9398-88f50a1521969

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7700-05009077000030 TABLET, FILM COATED in 1 BOTTLE (50090-7700-0) 2025-10-13NoNoCurrent
50090-7700-15009077000160 TABLET, FILM COATED in 1 BOTTLE (50090-7700-1) 2025-10-13NoNoCurrent
50090-7700-25009077000290 TABLET, FILM COATED in 1 BOTTLE (50090-7700-2) 2025-10-13NoNoCurrent