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
87d891bc-9286-4b87-a166-fccdf37fd520
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-362
Application NumberANDA076765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2011
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT