Zoloft
These highlights do not include all the information needed to use ZOLOFT safely and effectively. See full prescribing information for ZOLOFT. ZOLOFT (sertraline hydrochloride) tablets, for oral useZOLOFT (sertraline hydrochloride) oral solutionInitial U.S. Approval: 1991
Approved
Approval ID
fe9e8b7d-61ea-409d-84aa-3ebd79a046b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2023
Manufacturers
FDA
ROERIG
DUNS: 829076996
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sertraline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-4910
Application NumberNDA019839
Product Classification
M
Marketing Category
C73594
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2023
FDA Product Classification
INGREDIENTS (11)
SERTRALINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
sertraline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-0050
Application NumberNDA020990
Product Classification
M
Marketing Category
C73594
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2023
FDA Product Classification
INGREDIENTS (5)
SERTRALINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: UTI8907Y6X
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
sertraline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-4900
Application NumberNDA019839
Product Classification
M
Marketing Category
C73594
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2023
FDA Product Classification
INGREDIENTS (12)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
sertraline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-4960
Application NumberNDA019839
Product Classification
M
Marketing Category
C73594
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2023
FDA Product Classification
INGREDIENTS (14)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT