Escitalopram
These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
8e71923d-6a7c-a840-e053-2995a90ac7e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4984
Application NumberANDA078032
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (13)
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT