Lacosamide
These highlights do not include all the information needed to use LACOSAMIDE ORAL SOLUTION safely and effectively. See full prescribing information for LACOSAMIDE ORAL SOLUTION. LACOSAMIDE oral solution, CV Initial U.S. Approval: 2008
Approved
Approval ID
75de00d8-d2e7-4025-be4e-f49299068e7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
PAI Holdings, LLC
DUNS: 044940096
Products 4
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 Code0121-3036
Application NumberANDA216151
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (11)
LACOSAMIDEActive
Quantity: 150 mg in 15 mL
Code: 563KS2PQY5
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-4048
Application NumberANDA216151
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (11)
LACOSAMIDEActive
Quantity: 200 mg in 20 mL
Code: 563KS2PQY5
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-2024
Application NumberANDA216151
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (11)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
LACOSAMIDEActive
Quantity: 100 mg in 10 mL
Code: 563KS2PQY5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-1012
Application NumberANDA216151
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (11)
LACOSAMIDEActive
Quantity: 50 mg in 5 mL
Code: 563KS2PQY5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT