MedPath
FDA Product

Lacosamide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Lacosamide

53746-925

Regulatory Information

53746-925

ANDA204857

C73584

May 17, 2023

USA

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, for oral use, CV Initial U.S. Approval: 2008

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

123797875

Active Ingredients

LACOSAMIDE

Quantity: 150 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE (12 MPA.S AT 5%)

Code: 40UAA97IT9

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYVINYL ALCOHOL (94000 MW)

Code: C1MS7RRZ6L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

© Copyright 2025. All Rights Reserved by MedPath