escitalopram oxalate
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 USP, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
86cfcd96-6397-42ef-8a79-f62706f0aca6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code71335-0685
Application NumberANDA090939
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram oxalate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT