FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-0210
11-digit product format
713350210
Labeler code
71335
Product ID
71335-0210_f1cfc28f-bd82-4ffe-b413-5ef9d140a86f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077206
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0210-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
71335-0210-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6010
71335-0210-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9010
71335-0210-4Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED18010
71335-0210-5Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED2810
71335-0210-6Sertraline Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1510
71335-0210-7Sertraline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12010
71335-0210-8Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10010
71335-0210-9Sertraline Hydrochloride45 in 1 BOTTLETABLET, FILM COATED4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0210-1EA - Each71335-02106e198857-4051-4ca1-98f8-96fae153161612020-01-03
71335-0210-3EA - Each71335-0210f64f3b8c-a8e0-470e-a413-48f3041ca60112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0210SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240809_2f81b0c4-9ad9-4dda-8950-70321a8769e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN2f81b0c4-9ad9-4dda-8950-70321a8769e410
312938sertraline 100 MG Oral TabletSCD2f81b0c4-9ad9-4dda-8950-70321a8769e410
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY2f81b0c4-9ad9-4dda-8950-70321a8769e410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0210-17133502100130 TABLET, FILM COATED in 1 BOTTLE (71335-0210-1) 2019-06-120000-00-00NoNoCurrent
71335-0210-27133502100260 TABLET, FILM COATED in 1 BOTTLE (71335-0210-2) 2019-06-110000-00-00NoNoCurrent
71335-0210-37133502100390 TABLET, FILM COATED in 1 BOTTLE (71335-0210-3) 2019-05-210000-00-00NoNoCurrent
71335-0210-471335021004180 TABLET, FILM COATED in 1 BOTTLE (71335-0210-4) 2019-09-260000-00-00NoNoCurrent
71335-0210-57133502100528 TABLET, FILM COATED in 1 BOTTLE (71335-0210-5) 2021-12-270000-00-00NoNoCurrent
71335-0210-67133502100615 TABLET, FILM COATED in 1 BOTTLE (71335-0210-6) 2021-12-270000-00-00NoNoCurrent
71335-0210-771335021007120 TABLET, FILM COATED in 1 BOTTLE (71335-0210-7) 2021-12-270000-00-00NoNoCurrent
71335-0210-871335021008100 TABLET, FILM COATED in 1 BOTTLE (71335-0210-8) 2021-12-270000-00-00NoNoCurrent
71335-0210-97133502100945 TABLET, FILM COATED in 1 BOTTLE (71335-0210-9) 2021-12-270000-00-00NoNoCurrent