FDA.reportPublic FDA data

Sertraline

Product NDC
50090-0991
11-digit product format
500900991
Labeler code
50090
Product ID
50090-0991_da44577b-8f80-407b-8dae-d65a14118ede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline
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
50090-0991-0Sertraline30 in 1 BOTTLETABLET, FILM COATED3010
50090-0991-1Sertraline60 in 1 BOTTLETABLET, FILM COATED6010
50090-0991-2Sertraline90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0991-0EA - Each50090-099103101f14-c689-4151-8fb3-9f38fef4934712024-11-05
50090-0991-1EA - Each50090-0991dfd731c0-0e25-413e-a6bc-b092f9121e3f12024-11-05
50090-0991-2EA - Each50090-09917e711286-1948-44e5-a9d7-039f07c17ec012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0991SERTRALINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 3 package rows20241018_b2533b60-cc54-4905-a4ee-ea08a160f8c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNb2533b60-cc54-4905-a4ee-ea08a160f8c610
312938sertraline 100 MG Oral TabletSCDb2533b60-cc54-4905-a4ee-ea08a160f8c610
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYb2533b60-cc54-4905-a4ee-ea08a160f8c610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-0991-05009009910030 TABLET, FILM COATED in 1 BOTTLE (50090-0991-0) 2014-11-28NoNoHistorical
50090-0991-15009009910160 TABLET, FILM COATED in 1 BOTTLE (50090-0991-1) 2014-11-28NoNoHistorical
50090-0991-25009009910290 TABLET, FILM COATED in 1 BOTTLE (50090-0991-2) 2014-11-28NoNoHistorical