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, film coated for oral use, CV Initial U.S. Approval: 2008
Approved
Approval ID
07b7b3f2-16a0-4deb-883b-10522676d966
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-174
Application NumberANDA204974
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (13)
LACOSAMIDEActive
Quantity: 200 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-171
Application NumberANDA204974
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (15)
LACOSAMIDEActive
Quantity: 50 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-172
Application NumberANDA204974
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (13)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACOSAMIDEActive
Quantity: 100 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
lacosamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-173
Application NumberANDA204974
Product Classification
M
Marketing Category
C73584
G
Generic Name
lacosamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (15)
LACOSAMIDEActive
Quantity: 150 mg in 1 1
Code: 563KS2PQY5
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT