lacosamide oral solution (81033-427)

Drug Facts

Product Profile

Brand Name lacosamide oral solution

Generic Name lacosamide

Labeler kesin pharmaceutical corporation

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

lacosamide 10 mg/mL

Manufacturer

Kesin Pharmaceutical Corporation

Identifiers & Regulatory

Product NDC 81033-427

Product ID 81033-427_3ba29442-4e8b-c2b2-e063-6294a90a1bbf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA219699

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2025-08-05

Pharmacologic Class

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81033427

Hyphenated Format 81033-427

Supplemental Identifiers

RxCUI

993856

UNII

563KS2PQY5

NUI

N0000008486

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lacosamide oral solution (source: ndc)

Generic Name lacosamide (source: ndc)

Application Number ANDA219699 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

10 CUP, UNIT-DOSE in 1 CARTON (81033-427-14) / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05)
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-16) / 10 mL in 1 CUP, UNIT-DOSE (81033-427-10)
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-17) / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15)
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-18) / 20 mL in 1 CUP, UNIT-DOSE (81033-427-20)

source: ndc

Packages (4)

81033-427-14 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-14) / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05) 81033-427-16 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-16) / 10 mL in 1 CUP, UNIT-DOSE (81033-427-10) 81033-427-17 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-17) / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15) 81033-427-18 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-18) / 20 mL in 1 CUP, UNIT-DOSE (81033-427-20)

Ingredients (1)

lacosamide (10 mg/mL)

Linked Drug Pages (1)

Lacosamide Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3ba29442-4e8b-c2b2-e063-6294a90a1bbf", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["3ba29442-4e8a-c2b2-e063-6294a90a1bbf"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Kesin Pharmaceutical Corporation"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CARTON (81033-427-14)  / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05)", "package_ndc": "81033-427-14", "marketing_start_date": "20250805"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CARTON (81033-427-16)  / 10 mL in 1 CUP, UNIT-DOSE (81033-427-10)", "package_ndc": "81033-427-16", "marketing_start_date": "20250805"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CARTON (81033-427-17)  / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15)", "package_ndc": "81033-427-17", "marketing_start_date": "20250805"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CARTON (81033-427-18)  / 20 mL in 1 CUP, UNIT-DOSE (81033-427-20)", "package_ndc": "81033-427-18", "marketing_start_date": "20250805"}], "brand_name": "Lacosamide Oral Solution", "product_id": "81033-427_3ba29442-4e8b-c2b2-e063-6294a90a1bbf", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "81033-427", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Kesin Pharmaceutical Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide Oral Solution", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA219699", "marketing_category": "ANDA", "marketing_start_date": "20250805", "listing_expiration_date": "20261231"}