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
3bcd1a0c-a411-4318-bdd9-17b91c082ca1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 2
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 Code54458-892
Application NumberANDA076765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Escitalopram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-891
Application NumberANDA076765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT