FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
72865-205
11-digit product format
728650205
Labeler code
72865
Product ID
72865-205_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
25 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 HYDROCHLORIDE25 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
72865-205-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5003
72865-205-18SERTRALINE HYDROCHLORIDE180 in 1 BOTTLETABLET1803
72865-205-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET303
72865-205-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-205-05EA - Each72865-20502258174-5b5e-4b24-8770-f9480561bc7712022-02-07
72865-205-18EA - Each72865-205ebbe2f0a-d950-4e39-ba81-1116534f28ce12022-02-07
72865-205-30EA - Each72865-2058f8c752e-4d93-4f24-a927-23ed7b32b96b12022-02-07
72865-205-90EA - Each72865-20516c83d1b-ccb1-4e12-aea7-c7b96ad7b58c12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-205SERTRALINE 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
72865-205-0572865020505500 TABLET in 1 BOTTLE (72865-205-05) 500 tablet2021-05-030000-00-00NoNoCurrent
72865-205-1872865020518180 TABLET in 1 BOTTLE (72865-205-18) 180 tablet2021-05-030000-00-00NoNoCurrent
72865-205-307286502053030 TABLET in 1 BOTTLE (72865-205-30) 30 tablet2021-05-030000-00-00NoNoCurrent
72865-205-907286502059090 TABLET in 1 BOTTLE (72865-205-90) 90 tablet2021-05-030000-00-00NoNoCurrent