NDC Code(s) : 62332-171-30, 62332-171-60, 62332-171-91, 62332-171-10, 62332-172-30, 62332-172-60, 62332-172-91, 62332-172-10, 62332-173-30, 62332-173-60, 62332-173-91, 62332-173-10, 62332-174-30, 62332-174-60, 62332-174-71, 62332-174-10
Packager : Alembic Pharmaceuticals Inc.

Category : Human Prescription Drug Label

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lacosamide lacosamide TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-171
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
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 (Pink) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code 423
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-171-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:62332-171-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:62332-171-911000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
4NDC:62332-171-10100 in 1 CARTON 18/03/2022
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204974 03/18/2022
Lacosamide lacosamide TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-172
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (Dark) Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code L424
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-172-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:62332-172-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:62332-172-911000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
4NDC:62332-172-10100 in 1 CARTON 18/03/2022
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204974 03/18/2022
Lacosamide lacosamide TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-173
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color PINK (Deep Pink) Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code L425
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-173-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:62332-173-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:62332-173-911000 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
4NDC:62332-173-10100 in 1 CARTON 18/03/2022
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204974 03/18/2022
Lacosamide lacosamide TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-174
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code L426
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-174-3030 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
2NDC:62332-174-6060 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
3NDC:62332-174-71500 in 1 BOTTLE Type 0: Not a Combination Product18/03/2022
4NDC:62332-174-10100 in 1 CARTON 18/03/2022
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204974 03/18/2022

LABELER - Alembic Pharmaceuticals Inc.(079288842)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(62332-171, 62332-172, 62332-173, 62332-174)

PRINCIPAL DISPLAY PANEL

NDC 62332-171-30
Lacosamide Tablets,USP
50 mg
CV
ATTENTION PHARMACIST:
Each patient is required to receive
the accompanying Medication Guide.
Rx only
30 Tablets 
Alembic

30 tablets


PRINCIPAL DISPLAY PANEL

NDC 62332-172-30
Lacosamide Tablets, USP
100 mg
CV
ATTENTION PHARMACIST:
Each patient is required to receive
the accompanying Medication Guide.
Rx only
30 tablets
Alembic



PRINCIPAL DISPLAY PANEL

NDC 62332-173-30
Lacosamide Tablets, USP
150 mg
CV
ATTENTION PHARMACIST:
Each patient is required to receive
the accompanying Medication Guide.
Rx only
30 Tablets 
Alembic


30 tablets

PRINCIPAL DISPLAY PANEL

NDC 62332-174-30
Lacosamide Tablets, USP
200 mg
CV
ATTENTION PHARMACIST:
Each patient is required to receive
the accompanying Medication Guide.
Rx only
30 Tablets 
Alembic

30 tablets