Escitalopram
These highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002
Approved
Approval ID
5d28721d-097f-400e-8690-d133c76e07be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Escitalopram
PRODUCT DETAILS
NDC Product Code21695-725
Application NumberANDA076765
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 23, 2011
Generic NameEscitalopram
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
Boxed Warning section
LOINC: 34066-1Updated: 3/14/2012
WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS