SERTRALINE HYDROCHLORIDE

Product NDC
75921-490
11-digit product format
759210490
Labeler code
75921
Product ID
75921-490_547fccd0-546e-4e62-812d-9585ae02721f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Life Line Home Care Services
Application
NDA019839
Marketing category
NDA
Marketing start
1992-02-11
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75921-490-302019-11-13C16284748780-197449f38-cefc-f6ea-e053-dbdaa90aa703SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75921-490-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sertraline hydrochlorideACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
sertralineACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75921-490SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES]1Legacy NDC, 1 package rows20120307_9222a610-a6d9-4b06-8ea0-c23a9ba8e281.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN9222a610-a6d9-4b06-8ea0-c23a9ba8e2811
312941sertraline 50 MG Oral TabletSCD9222a610-a6d9-4b06-8ea0-c23a9ba8e2811
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY9222a610-a6d9-4b06-8ea0-c23a9ba8e2811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75921-490-307592104903030 in 1 BOTTLEHistorical