lacosamide film coated tablet, for oral use, cv

SPL v2

SPL

SPL Set ID 0ae4e2d1-305d-4045-95da-cfe7c2d8b435

Route

oral

Published

Effective Date 2022-04-21

Document Type 34391-3 Human Prescription Drug Label

Drug Facts

Composition & Product

Active Ingredients

lacosamide (50 mg)

Inactive Ingredients

crospovidone (120 .mu.m) low-substituted hydroxypropyl cellulose, unspecified microcrystalline cellulose fd&c blue no. 2 ferric oxide red ferrosoferric oxide hydroxypropyl cellulose (1600000 wamw) lecithin, soybean magnesium stearate polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide talc titanium dioxide ferric oxide yellow

Identifiers & Packaging

Pill Appearance

Imprint: 114 Shape: oval Color: pink Color: yellow Color: brown Color: blue Size: 10 mm Size: 13 mm Size: 15 mm Size: 17 mm Score: 1

Marketing Status

anda active Since 2022-03-19

Description

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

Medication Information

Description

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

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"strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (1600000 WAMW)", "unii": "RFW2ET671P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", 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"TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACOSAMIDE", "unii": "563KS2PQY5", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "2165RE0K14", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (1600000 WAMW)", "unii": "RFW2ET671P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:36:50.589668 · Updated: 2026-03-14T21:47:42.884935