Label: LACOSAMIDE tablet, film coated
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NDC Code(s):
69539-025-05,
69539-025-60,
69539-026-05,
69539-026-60, view more69539-027-05, 69539-027-60, 69539-028-05, 69539-028-60
- Packager: MSN LABORATORIES PRIVATE LIMITED
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 21, 2022
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- Medication Guide: HTML
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- MEDICATION GUIDE
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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
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INGREDIENTS AND APPEARANCE
LACOSAMIDE
lacosamide tablet, film coatedProduct 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 coatedProduct 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 coatedProduct 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 coatedProduct 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)