FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
72865-207
11-digit product format
728650207
Labeler code
72865
Product ID
72865-207_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
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, 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
72865-207-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5003
72865-207-18SERTRALINE HYDROCHLORIDE180 in 1 BOTTLETABLET1803
72865-207-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET303
72865-207-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-207-05EA - Each72865-2071070bb89-66a5-4eba-a909-8caf5e7fec9f12022-02-07
72865-207-18EA - Each72865-207a0f87c01-5865-4f48-9428-a70734db103512022-02-07
72865-207-30EA - Each72865-207535e03f8-3676-470e-b875-365c7743689e12022-02-07
72865-207-90EA - Each72865-207bd29a974-7614-43dc-bf6b-fd45b5fad68d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-207SERTRALINE 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
72865-207-0572865020705500 TABLET in 1 BOTTLE (72865-207-05) 500 tablet2021-05-030000-00-00NoNoCurrent
72865-207-1872865020718180 TABLET in 1 BOTTLE (72865-207-18) 180 tablet2021-05-030000-00-00NoNoCurrent
72865-207-307286502073030 TABLET in 1 BOTTLE (72865-207-30) 30 tablet2021-05-030000-00-00NoNoCurrent
72865-207-907286502079090 TABLET in 1 BOTTLE (72865-207-90) 90 tablet2021-05-030000-00-00NoNoCurrent