escitalopram
These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
64af4d9f-1190-4217-824f-978f037e4810
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
escitalopram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-079
Application NumberANDA078777
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (10)
ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
escitalopram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-078
Application NumberANDA078777
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
escitalopram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-077
Application NumberANDA078777
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 5 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT