LACOSAMIDE
These highlights do not include all the information needed to use LACOSAMIDE INJECTION safely and effectively. See full prescribing information for LACOSAMIDE INJECTION. LACOSAMIDE injection, for intravenous use, CV Initial U.S. Approval: 2008
Approved
Approval ID
01162e2f-967b-4596-8188-c0d9889c3814
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2023
Manufacturers
FDA
Virtus Pharmaceuticals, LLC
DUNS: 079659493
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LACOSAMIDE
PRODUCT DETAILS
NDC Product Code69543-455
Application NumberANDA215628
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 1, 2023
Generic NameLACOSAMIDE
INGREDIENTS (4)
LACOSAMIDEActive
Quantity: 10 mg in 1 mL
Code: 563KS2PQY5
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT