FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
71205-047
11-digit product format
712050047
Labeler code
71205
Product ID
71205-047_cbf2683a-b8ea-49b3-a0a0-63c69d70f2fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
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, 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
71205-047-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
71205-047-60SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED603
71205-047-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-047SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191122_6b532e6a-b040-4a10-a242-fb6d8dfc0852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline HCl 50 MG Oral TabletPSN6b532e6a-b040-4a10-a242-fb6d8dfc08523
312938sertraline 100 MG Oral TabletSCD6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline 50 MG Oral TabletSCD6b532e6a-b040-4a10-a242-fb6d8dfc08523
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY6b532e6a-b040-4a10-a242-fb6d8dfc08523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-047-307120500473030 TABLET, FILM COATED in 1 BOTTLE (71205-047-30) 2018-06-010000-00-00NoNoCurrent
71205-047-607120500476060 TABLET, FILM COATED in 1 BOTTLE (71205-047-60) 2018-06-010000-00-00NoNoCurrent
71205-047-907120500479090 TABLET, FILM COATED in 1 BOTTLE (71205-047-90) 2018-06-010000-00-00NoNoCurrent