FDA.reportPublic FDA data

SERTRALINE

Product NDC
61919-457
11-digit product format
619190457
Labeler code
61919
Product ID
61919-457_3fb439b4-486d-092a-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077397
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
61919-457-30SERTRALINE30 in 1 BOTTLETABLET302
61919-457-60SERTRALINE60 in 1 BOTTLETABLET602
61919-457-90SERTRALINE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-457-30EA - Each61919-457715a7cf5-0970-4350-86f0-00dd41ff711c12015-10-02
61919-457-60EA - Each61919-457287a2aca-7b68-4c71-95e3-7c12184e0a8312014-05-02
61919-457-90EA - Each61919-4572f166127-cb92-4d12-bdd9-3f3e225cfcf412014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE TABLET [DIRECT RX]1
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE TABLET [DIRECT RX]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE TABLET [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE TABLET [DIRECT RX]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSERTRALINE TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82SERTRALINE TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-457SERTRALINE TABLET [DIRECT RX]2Legacy NDC, 3 package rows20161025_347db8a2-b214-4bb7-953a-2dad1076ab37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN347db8a2-b214-4bb7-953a-2dad1076ab372
312941sertraline HCl 50 MG Oral TabletPSN347db8a2-b214-4bb7-953a-2dad1076ab372
312938sertraline 100 MG Oral TabletSCD347db8a2-b214-4bb7-953a-2dad1076ab372
312941sertraline 50 MG Oral TabletSCD347db8a2-b214-4bb7-953a-2dad1076ab372
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY347db8a2-b214-4bb7-953a-2dad1076ab372
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY347db8a2-b214-4bb7-953a-2dad1076ab372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-457-306191904573030 in 1 BOTTLEHistorical
61919-457-606191904576060 in 1 BOTTLEHistorical
61919-457-906191904579090 in 1 BOTTLEHistorical