LEXAPRO
These highlights do not include all the information needed to use Lexapro® safely and effectively. See full prescribing information for Lexapro®Lexapro® (escitalopram oxalate) TabletsLexapro® (escitalopram oxalate) Oral SolutionInitial U.S. Approval: 2002
Approved
Approval ID
3750b79d-8dac-46c1-82d1-cfe9bcac6a86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 16, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ESCITALOPRAM OXALATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-139
Application NumberNDA021323
Product Classification
M
Marketing Category
C73594
G
Generic Name
ESCITALOPRAM OXALATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (9)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
ESCITALOPRAM OXALATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-833
Application NumberNDA021323
Product Classification
M
Marketing Category
C73594
G
Generic Name
ESCITALOPRAM OXALATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (9)
ESCITALOPRAM OXALATEActive
Quantity: 5 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT