LACOSAMIDE tablet, film coated

lacosamide by

Drug Labeling and Warnings

lacosamide by is a Prescription medication manufactured, distributed, or labeled by MSN LABORATORIES PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69539-025-60

Lacosamide Tablet, USP 

50 mg

Rx Only

PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT

60 Tablets

NDC: 69539-026-60

Lacosamide Tablet, USP 

100 mg

Rx Only

PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT

60 Tablets

NDC: 69539-027-60

Lacosamide Tablet, USP 

150 mg

Rx Only

PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT

60 Tablets

NDC: 69539-028-60

Lacosamide Tablet, USP 

200 mg

Rx Only

PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT

60 Tablets

INGREDIENTS AND APPEARANCE

LACOSAMIDE 
lacosamide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69539-025
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)	LACOSAMIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69539-025-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022
2	NDC: 69539-025-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204921	03/19/2022

LACOSAMIDE 
lacosamide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69539-026
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)	LACOSAMIDE	100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69539-026-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022
2	NDC: 69539-026-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204921	03/19/2022

LACOSAMIDE 
lacosamide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69539-027
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)	LACOSAMIDE	150 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (tan)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	113
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69539-027-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022
2	NDC: 69539-027-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204921	03/19/2022

LACOSAMIDE 
lacosamide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69539-028
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)	LACOSAMIDE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69539-028-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022
2	NDC: 69539-028-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204921	03/19/2022

Labeler - MSN LABORATORIES PRIVATE LIMITED (650786952)

Establishment
Name	Address	ID/FEI	Business Operations
MSN LABORATORIES PRIVATE LIMITED		650786952	ANALYSIS(69539-025, 69539-026, 69539-027, 69539-028) , MANUFACTURE(69539-025, 69539-026, 69539-027, 69539-028)