MedPath

escitalopram

ESCITALOPRAM TABLETS

Approved
Approval ID

76d0e2a8-2ed2-4596-9179-8c360f4a0978

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 5, 2022

Manufacturers
FDA

Zydus Lifesciences Limited

DUNS: 918596198

Products 3

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 Code70771-1145
Application NumberANDA077734
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (9)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 5 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

escitalopram

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1147
Application NumberANDA077734
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (9)

ESCITALOPRAM OXALATEActive
Quantity: 20 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

escitalopram

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1146
Application NumberANDA077734
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (9)

ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

escitalopram - FDA Drug Approval Details