FDA.reportPublic FDA data

Zoloft

Product NDC
0049-4900
11-digit product format
000494900
Labeler code
0049
Product ID
0049-4900_842b5b3f-e0f0-4a16-bb47-2750a605452c
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
2026-06-30
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zoloft

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066

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
0049-4900-30Zoloft30 in 1 BOTTLETABLET, FILM COATED3068
0049-4900-41Zoloft1 in 1 BLISTER PACKTABLET, FILM COATED168
0049-4900-41Zoloft100 in 1 CARTONTABLET, FILM COATED10068
0049-4900-66Zoloft100 in 1 BOTTLETABLET, FILM COATED10068
0049-4900-73Zoloft500 in 1 BOTTLETABLET, FILM COATED50068
0049-4900-94Zoloft5000 in 1 BOTTLETABLET, FILM COATED500068

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-4900-30EA - Each0049-490058658304-1be6-43e3-a573-4c194d82918012012-07-24
0049-4900-41EA - Each0049-49002e5b8289-16b3-484f-9bdd-edc7d41dfd9712012-07-24

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
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
sertralineACTIVE MOIETYQUC7NX6WMBZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-4900ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG]66Current NDC, Legacy NDC, 6 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
312938sertraline HCl 100 MG Oral TabletPSNc3b0b1f8-abfd-4054-8645-fd076305f4f81
312941sertraline HCl 50 MG Oral TabletPSNc3b0b1f8-abfd-4054-8645-fd076305f4f81
208149Zoloft 100 MG Oral TabletPSNc3b0b1f8-abfd-4054-8645-fd076305f4f81
208161Zoloft 50 MG Oral TabletPSNc3b0b1f8-abfd-4054-8645-fd076305f4f81
208149sertraline 100 MG Oral Tablet [Zoloft]SBDc3b0b1f8-abfd-4054-8645-fd076305f4f81
208161sertraline 50 MG Oral Tablet [Zoloft]SBDc3b0b1f8-abfd-4054-8645-fd076305f4f81
312938sertraline 100 MG Oral TabletSCDc3b0b1f8-abfd-4054-8645-fd076305f4f81
312941sertraline 50 MG Oral TabletSCDc3b0b1f8-abfd-4054-8645-fd076305f4f81
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc3b0b1f8-abfd-4054-8645-fd076305f4f81
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYc3b0b1f8-abfd-4054-8645-fd076305f4f81
208149Zoloft (as sertraline hydrochloride) 100 MG Oral TabletSYc3b0b1f8-abfd-4054-8645-fd076305f4f81
208161Zoloft (as sertraline hydrochloride) 50 MG Oral TabletSYc3b0b1f8-abfd-4054-8645-fd076305f4f81
208161Zoloft 50 MG Oral TabletSYc3b0b1f8-abfd-4054-8645-fd076305f4f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-4900-300004949003030 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) 1992-02-112026-06-30NoNoCurrent
0049-4900-4100049490041100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack1992-02-112026-06-30NoNoCurrent
0049-4900-6600049490066100 TABLET, FILM COATED in 1 BOTTLE (0049-4900-66) 1992-02-110000-00-00NoNoCurrent
0049-4900-7300049490073500 TABLET, FILM COATED in 1 BOTTLE (0049-4900-73) 1992-02-110000-00-00NoNoCurrent
0049-4900-94000494900945000 TABLET, FILM COATED in 1 BOTTLE (0049-4900-94) 1992-02-110000-00-00NoNoCurrent