NDC Code(s) : 16714-548-01, 16714-549-01, 16714-550-01, 16714-552-01
Packager : NorthStar RxLLC

Category : Human Prescription Drug Label

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lacosamide Lacosamide TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-548
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)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code I73
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-548-0160 in 1 BOTTLE Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208308 08/01/2022
Lacosamide Lacosamide TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-549
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)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (Dark Yellow) Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code I74
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-549-0160 in 1 BOTTLE Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208308 08/01/2022
Lacosamide Lacosamide TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-550
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)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color ORANGE (Peach) Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code I75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-550-0160 in 1 BOTTLE Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208308 08/01/2022
Lacosamide Lacosamide TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-552
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)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code I76
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-552-0160 in 1 BOTTLE Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208308 08/01/2022

LABELER - NorthStar RxLLC(830546433)

Establishment
Name Address ID/FEI Business Operations
INDOCO REMEDIES LIMITED 915851870 ANALYSIS(16714-548, 16714-549, 16714-550, 16714-552), MANUFACTURE(16714-548, 16714-549, 16714-550, 16714-552)