Lacosamide

Basic Information

Product Name

Lacosamide

FDA Product Code

69367-351

Regulatory Information

NDC Product Code

69367-351

Application Number

ANDA205237

Marketing Category

C73584

Effective Date

June 1, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS. LACOSAMIDE tablets, film coated tablet, for oral use, CV Initial U.S. Approval: 2008

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

LACOSAMIDE

Quantity: 200 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

Active Moieties

Code: 563KS2PQY5

Lacosamide

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

MAGNESIUM STEARATE

CROSPOVIDONE, UNSPECIFIED

MICROCRYSTALLINE CELLULOSE

HYPROMELLOSE 2910 (6 MPA.S)

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL, UNSPECIFIED

FD&C BLUE NO. 2

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Active Moieties

LACOSAMIDE