Eslicarbazepine acetate

Basic Information

Product Name

FDA Product Code

31722-430

Regulatory Information

NDC Product Code

31722-430

Application Number

ANDA211186

Marketing Category

C73584

Effective Date

September 7, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ESLICARBAZEPINE ACETATE TABLETS safely and effectively. See full prescribing information for ESLICARBAZEPINE ACETATE TABLETS. ESLICARBAZEPINE ACETATE tablets, for oral use Initial U.S. Approval: 2013

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

POVIDONE K90

Code: RDH86HJV5Z

Class Code: IACT

ESLICARBAZEPINE ACETATE

Quantity: 600 mg in 1 1

Code: BEA68ZVB2K

Class Code: ACTIB

Active Moieties