Vimpat
These highlights do not include all the information needed to use VIMPAT safely and effectively. See full prescribing information for VIMPAT. VIMPAT (lacosamide) Tablet, Film Coated for Oral use, CV VIMPAT (lacosamide) Injection for Intravenous use, CV VIMPAT (lacosamide) Oral Solution, CVInitial U.S. Approval: 2008
Approved
Approval ID
1310e776-65c8-413d-aab5-81a8c15719c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6077
Application NumberNDA022253
Product Classification
M
Marketing Category
C73594
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2012
FDA Product Classification
INGREDIENTS (16)
lacosamideActive
Quantity: 50 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
indigotindisulfonate sodiumInactive
Code: D3741U8K7L
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT