FDA.reportPublic FDA data

Zoloft

Product NDC
0049-4960
11-digit product format
000494960
Labeler code
0049
Product ID
0049-4960_ca266f27-bd08-49ba-8d79-a6dba8699bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Roerig
Application
NDA019839
Marketing category
NDA
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],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-4960-30Zoloft30 in 1 BOTTLETABLET, FILM COATED3068
0049-4960-50Zoloft50 in 1 BOTTLETABLET, FILM COATED5068

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-4960-30EA - Each0049-4960fbc0b310-a8cb-47b1-aefb-66fa0a95ece412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
SERTRALINEACTIVE MOIETYQUC7NX6WMBZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
ALCOHOLINACTIVE INGREDIENT3K9958V90MZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-4960ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]66Legacy NDC, 2 package rows20241206_fe9e8b7d-61ea-409d-84aa-3ebd79a046b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861064sertraline HCl 20 MG in 1 mL Concentrate for Oral SolutionPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312940sertraline HCl 25 MG Oral TabletPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312941sertraline HCl 50 MG Oral TabletPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208149Zoloft 100 MG Oral TabletPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861066Zoloft 20 MG in 1 mL Concentrate for Oral SolutionPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
212233Zoloft 25 MG Oral TabletPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208161Zoloft 50 MG Oral TabletPSNfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208149sertraline 100 MG Oral Tablet [Zoloft]SBDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861066sertraline 20 MG/ML Oral Solution [Zoloft]SBDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
212233sertraline 25 MG Oral Tablet [Zoloft]SBDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208161sertraline 50 MG Oral Tablet [Zoloft]SBDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312938sertraline 100 MG Oral TabletSCDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861064sertraline 20 MG/ML Oral SolutionSCDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312940sertraline 25 MG Oral TabletSCDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312941sertraline 50 MG Oral TabletSCDfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861064sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral SolutionSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208149Zoloft (as sertraline hydrochloride) 100 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861066Zoloft (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral SolutionSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
212233Zoloft (as sertraline hydrochloride) 25 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208161Zoloft (as sertraline hydrochloride) 50 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
861066Zoloft 20 MG per 1 ML Concentrate for Oral SolutionSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
212233Zoloft 25 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568
208161Zoloft 50 MG Oral TabletSYfe9e8b7d-61ea-409d-84aa-3ebd79a046b568

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0049-4960-300004949603030 TABLET, FILM COATED in 1 BOTTLE (0049-4960-30) 1992-02-110000-00-00NoNoCurrent
0049-4960-500004949605050 TABLET, FILM COATED in 1 BOTTLE (0049-4960-50) 1992-02-110000-00-00NoNoCurrent