FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
71205-455
11-digit product format
712050455
Labeler code
71205
Product ID
71205-455_4fe238eb-0703-4011-bca9-6c376e9b4314
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
71205-455-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
71205-455-60Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
71205-455-90Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-455-30EA - Each71205-45557f7b96f-8123-4539-a845-e2a90075c8d412020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-455SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221211_0f264823-1cba-4478-aef1-a8587f221dbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN0f264823-1cba-4478-aef1-a8587f221dbb2
312938sertraline 100 MG Oral TabletSCD0f264823-1cba-4478-aef1-a8587f221dbb2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY0f264823-1cba-4478-aef1-a8587f221dbb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-455-307120504553030 TABLET, FILM COATED in 1 BOTTLE (71205-455-30) 2020-06-090000-00-00NoNoCurrent
71205-455-607120504556060 TABLET, FILM COATED in 1 BOTTLE (71205-455-60) 2020-06-090000-00-00NoNoCurrent
71205-455-907120504559090 TABLET, FILM COATED in 1 BOTTLE (71205-455-90) 2020-06-090000-00-00NoNoCurrent