SERTRALINE HYDROCHLORIDE
These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1991
Approved
Approval ID
5b73a90e-b883-419b-b30f-a379eed764d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2023
Manufacturers
FDA
XLCare Pharmaceuticals, Inc.
DUNS: 080991142
Products 3
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 Code72865-206
Application NumberANDA214790
Product Classification
M
Marketing Category
C73584
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (11)
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code72865-207
Application NumberANDA214790
Product Classification
M
Marketing Category
C73584
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (12)
SERTRALINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
sertraline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-205
Application NumberANDA214790
Product Classification
M
Marketing Category
C73584
G
Generic Name
sertraline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (12)
SERTRALINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT