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
1df5c652-7bad-4b07-b33b-333071bc2670
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-325
Application NumberANDA202389
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM