lacosamide
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
Approved
Approval ID
df1d2e6a-6129-49c9-b2c1-0fdf73f38b9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2023
Manufacturers
FDA
Glenmark Pharmaceuticals Inc. USA
DUNS: 130597813
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 Code68462-680
Application NumberANDA205006
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (15)
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACOSAMIDEActive
Quantity: 150 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-678
Application NumberANDA205006
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (15)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACOSAMIDEActive
Quantity: 50 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-679
Application NumberANDA205006
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (13)
LACOSAMIDEActive
Quantity: 100 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-681
Application NumberANDA205006
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (13)
LACOSAMIDEActive
Quantity: 200 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT