NDC Code(s) : 68462-678-30, 68462-678-60, 68462-678-10, 68462-679-30, 68462-679-60, 68462-679-10, 68462-680-30, 68462-680-60, 68462-680-10, 68462-681-30, 68462-681-60, 68462-681-10
Packager : Glenmark Pharmaceuticals Inc. USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

lacosamidelacosamide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-678
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACOSAMIDE(UNII: 563KS2PQY5)
(LACOSAMIDE - UNII:563KS2PQY5) 		LACOSAMIDE50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color PINK (light pink) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code G;678
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-678-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:68462-678-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:68462-678-101000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205006 03/18/2022
lacosamidelacosamide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-679
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACOSAMIDE(UNII: 563KS2PQY5)
(LACOSAMIDE - UNII:563KS2PQY5) 		LACOSAMIDE100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code G;679
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-679-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:68462-679-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:68462-679-101000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205006 03/18/2022
lacosamidelacosamide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-680
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACOSAMIDE(UNII: 563KS2PQY5)
(LACOSAMIDE - UNII:563KS2PQY5) 		LACOSAMIDE150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code G;680
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-680-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:68462-680-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:68462-680-101000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205006 03/18/2022
lacosamidelacosamide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-681
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACOSAMIDE(UNII: 563KS2PQY5)
(LACOSAMIDE - UNII:563KS2PQY5) 		LACOSAMIDE200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code G;681
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-681-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:68462-681-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:68462-681-101000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205006 03/18/2022

LABELER - Glenmark Pharmaceuticals Inc. USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Ltd. 862603186 ANALYSIS(68462-678, 68462-679, 68462-680, 68462-681), MANUFACTURE(68462-678, 68462-679, 68462-680, 68462-681)

PRINCIPAL DISPLAY PANEL

NDC 68462-678-60
Lacosamide Tablets, USP 50 mg – CV

Pharmacist: Dispense the Medication Guide provided separately to each patient.

Rx only

60 Tablets

50mg-label

PRINCIPAL DISPLAY PANEL

NDC 68462-679-60
Lacosamide Tablets, USP 100 mg – CV

Pharmacist: Dispense the Medication Guide provided separately to each patient.

Rx only

60 Tablets

100mg-label

PRINCIPAL DISPLAY PANEL

NDC 68462-680-60
Lacosamide Tablets, USP 150 mg – CV

Pharmacist: Dispense the Medication Guide provided separately to each patient.

Rx only

60 Tablets

150mg-label

PRINCIPAL DISPLAY PANEL

NDC 68462-681-60
Lacosamide Tablets, USP 200 mg – CV

Pharmacist: Dispense the Medication Guide provided separately to each patient.

Rx only

60 Tablets

200mg-label