SERTRALINE HYDROCHLORIDE

Product NDC
59762-4900
11-digit product format
597624900
Labeler code
59762
Product ID
59762-4900_9d3f92ee-245e-4a54-9e09-52cd1bd6aea8
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
2006-03-20
Marketing end
2019-09-30
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
0000-00-00
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
59762-4900-1EA - Each59762-49006f3347fa-7708-4f6a-87ea-d93b7279da2b12012-07-24
59762-4900-2EA - Each59762-4900ee9ee0bc-3f70-40a1-822a-a1c71e627c9812012-07-24
59762-4900-3EA - Each59762-49005868c75f-3c2f-4564-8a67-e64ae5d7eba512012-07-24
59762-4900-4EA - Each59762-490032c99274-7243-43a1-97c8-a88a6cc2cf3912012-07-24
59762-4900-5EA - Each59762-4900ff99ba0b-b92d-46ff-9c1b-2badc5b3031b12012-07-24

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 [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 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
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