Escitalopram oxalate
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 useInitial U.S. Approval: 2002
Approved
Approval ID
8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Exelan Pharmaceuticals Inc.
DUNS: 967795266
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 Code76282-250
Application NumberANDA078604
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
escitalopram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-251
Application NumberANDA078604
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (11)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
escitalopram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-249
Application NumberANDA078604
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (11)
ESCITALOPRAM OXALATEActive
Quantity: 5 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT