SERTRALINE HYDROCHLORIDE

Product NDC
59762-4960
11-digit product format
597624960
Labeler code
59762
Product ID
59762-4960_e8b9ac1b-99e2-4eaa-adba-6c9ce4e254d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA019839
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1992-02-11
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-4960-1EA - Each59762-4960a8fd5ffc-4106-4d7a-bd27-ed4826429f3d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]8

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNdfc0d446-cdc0-402b-a094-eae9f11155088
312940sertraline HCl 25 MG Oral TabletPSNdfc0d446-cdc0-402b-a094-eae9f11155088
312941sertraline HCl 50 MG Oral TabletPSNdfc0d446-cdc0-402b-a094-eae9f11155088
312938sertraline 100 MG Oral TabletSCDdfc0d446-cdc0-402b-a094-eae9f11155088
312940sertraline 25 MG Oral TabletSCDdfc0d446-cdc0-402b-a094-eae9f11155088
312941sertraline 50 MG Oral TabletSCDdfc0d446-cdc0-402b-a094-eae9f11155088
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYdfc0d446-cdc0-402b-a094-eae9f11155088
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYdfc0d446-cdc0-402b-a094-eae9f11155088
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYdfc0d446-cdc0-402b-a094-eae9f11155088