FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
72865-206
11-digit product format
728650206
Labeler code
72865
Product ID
72865-206_918e3fe6-8b38-4ec8-accb-09b2d82ff404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
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
Rxcui312938, 312940, 312941

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
72865-206-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5003
72865-206-18SERTRALINE HYDROCHLORIDE180 in 1 BOTTLETABLET1803
72865-206-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET303
72865-206-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-206-05EA - Each72865-2063d2cbd2f-c9d6-4bf8-9892-ea6df124fbaf12022-02-07
72865-206-18EA - Each72865-206eb916110-b9c8-4596-b222-6bdd6137c33f12022-02-07
72865-206-30EA - Each72865-2061c9793a7-04ea-447a-871b-3ef8bcdc365312022-02-07
72865-206-90EA - Each72865-206a8b4dc1d-4b14-41e8-8a10-da53180241ab12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-206SERTRALINE HYDROCHLORIDE TABLET [XLCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20230928_5b73a90e-b883-419b-b30f-a379eed764d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN5b73a90e-b883-419b-b30f-a379eed764d93
312940sertraline HCl 25 MG Oral TabletPSN5b73a90e-b883-419b-b30f-a379eed764d93
312941sertraline HCl 50 MG Oral TabletPSN5b73a90e-b883-419b-b30f-a379eed764d93
312938sertraline 100 MG Oral TabletSCD5b73a90e-b883-419b-b30f-a379eed764d93
312940sertraline 25 MG Oral TabletSCD5b73a90e-b883-419b-b30f-a379eed764d93
312941sertraline 50 MG Oral TabletSCD5b73a90e-b883-419b-b30f-a379eed764d93
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY5b73a90e-b883-419b-b30f-a379eed764d93
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY5b73a90e-b883-419b-b30f-a379eed764d93
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY5b73a90e-b883-419b-b30f-a379eed764d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-206-0572865020605500 TABLET in 1 BOTTLE (72865-206-05) 500 tablet2021-05-030000-00-00NoNoCurrent
72865-206-1872865020618180 TABLET in 1 BOTTLE (72865-206-18) 180 tablet2021-05-030000-00-00NoNoCurrent
72865-206-307286502063030 TABLET in 1 BOTTLE (72865-206-30) 30 tablet2021-05-030000-00-00NoNoCurrent
72865-206-907286502069090 TABLET in 1 BOTTLE (72865-206-90) 90 tablet2021-05-030000-00-00NoNoCurrent