SERTRALINE HYDROCHLORIDE

Product NDC
59762-4910
11-digit product format
597624910
Labeler code
59762
Product ID
59762-4910_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
100 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
59762-4910-1EA - Each59762-4910f301706c-efed-4503-9283-8c49ef3121f012012-07-24
59762-4910-2EA - Each59762-491052f8caa8-177d-43c6-81be-f7c2cc1e25d912012-07-24
59762-4910-3EA - Each59762-4910facb404f-6db7-4a73-a0cf-6d9129ff7c3612012-07-24
59762-4910-4EA - Each59762-4910bdf265f1-ebb6-40a2-b4c3-7d7926733e7812012-07-24
59762-4910-5EA - Each59762-491045657274-9925-418b-a437-38298747cb9e12012-07-24

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
sertraline hydrochlorideACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
sertralineACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
sertralineACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

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
312938sertraline HCl 100 MG Oral TabletPSN13bbfcfe-24c8-4ca5-b119-918d1ab7aa371
312938sertraline HCl 100 MG Oral TabletPSN3e2cb0ae-2284-44d0-9eff-f7d4ab6501a51
312938sertraline 100 MG Oral TabletSCD13bbfcfe-24c8-4ca5-b119-918d1ab7aa371
312938sertraline 100 MG Oral TabletSCD3e2cb0ae-2284-44d0-9eff-f7d4ab6501a51
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY13bbfcfe-24c8-4ca5-b119-918d1ab7aa371
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY3e2cb0ae-2284-44d0-9eff-f7d4ab6501a51