SERTRALINE

Product NDC
50436-6304
11-digit product format
504366304
Labeler code
50436
Product ID
50436-6304_0f5f2a54-442a-4653-bdf5-8b351956d0f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077397
Marketing category
ANDA
Marketing start
2007-10-18
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
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-6304-12020-01-31C16284748780-19d75b9d0-5fbc-f424-e053-dadaa90a57ceSERTRALINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6304-1SERTRALINE30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6304-1EA - Each50436-63044666f5df-21aa-4c97-8183-92b5f5d8c09912012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6304SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20170728_31fd504e-5955-49f9-a77e-2720a126fbc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN31fd504e-5955-49f9-a77e-2720a126fbc76
312941sertraline 50 MG Oral TabletSCD31fd504e-5955-49f9-a77e-2720a126fbc76
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY31fd504e-5955-49f9-a77e-2720a126fbc76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6304-15043663040130 in 1 BOTTLEHistorical