FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71335-0403
11-digit product format
713350403
Labeler code
71335
Product ID
71335-0403_1ec34f1e-b59c-4cff-b867-eb1465506cd1
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
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
Rxcui312941

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
71335-0403-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30106
71335-0403-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60106
71335-0403-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90106
71335-0403-4Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180106
71335-0403-5Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100106
71335-0403-6Sertraline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56106
71335-0403-7Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28106
71335-0403-8Sertraline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120106
71335-0403-9Sertraline Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0403-1EA - Each71335-0403e99aeeb9-5671-4973-b44e-002e13cf547b12019-11-12
71335-0403-2EA - Each71335-0403d0178d74-eab0-4bf6-89f6-444bb715f9c112021-12-08
71335-0403-3EA - Each71335-040392a5dcf8-b101-4ef2-a0b9-88077c0a57af12021-12-08
71335-0403-4EA - Each71335-0403dddf6283-5d4b-4989-b5d1-47027177a55512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0403SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 9 package rows20240821_c6897cf2-1349-400d-ab22-1e88f097b693.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSNc6897cf2-1349-400d-ab22-1e88f097b693106
312941sertraline 50 MG Oral TabletSCDc6897cf2-1349-400d-ab22-1e88f097b693106
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYc6897cf2-1349-400d-ab22-1e88f097b693106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0403-17133504030130 TABLET, FILM COATED in 1 BOTTLE (71335-0403-1) 2019-04-100000-00-00NoNoCurrent
71335-0403-27133504030260 TABLET, FILM COATED in 1 BOTTLE (71335-0403-2) 2019-04-110000-00-00NoNoCurrent
71335-0403-37133504030390 TABLET, FILM COATED in 1 BOTTLE (71335-0403-3) 2019-04-190000-00-00NoNoCurrent
71335-0403-471335040304180 TABLET, FILM COATED in 1 BOTTLE (71335-0403-4) 2019-09-260000-00-00NoNoCurrent
71335-0403-571335040305100 TABLET, FILM COATED in 1 BOTTLE (71335-0403-5) 2024-04-050000-00-00NoNoCurrent
71335-0403-67133504030656 TABLET, FILM COATED in 1 BOTTLE (71335-0403-6) 2019-04-150000-00-00NoNoCurrent
71335-0403-77133504030728 TABLET, FILM COATED in 1 BOTTLE (71335-0403-7) 2024-04-050000-00-00NoNoCurrent
71335-0403-871335040308120 TABLET, FILM COATED in 1 BOTTLE (71335-0403-8) 2024-04-050000-00-00NoNoCurrent
71335-0403-97133504030915 TABLET, FILM COATED in 1 BOTTLE (71335-0403-9) 2024-04-050000-00-00NoNoCurrent