FDA.reportPublic FDA data

NDC 81033-427-05 - Lacosamide Oral Solution

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
81033-427
Requested NDC
81033-427-05
Package NDCs from labels
81033-427-05, 81033-427-14, 81033-427-10, 81033-427-16, 81033-427-15, 81033-427-17, 81033-427-20, 81033-427-18
Manufacturer
Kesin Pharmaceutical Corporation
Effective date
2025-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lacosamide Oral Solution - Kesin Pharmaceutical CorporationKesin Pharmaceutical Corporation2025-08-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-427-05Lacosamide Oral Solution5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-427-10Lacosamide Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION101
81033-427-14Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-15Lacosamide Oral Solution15 mL in 1 CUP, UNIT-DOSESOLUTION151
81033-427-16Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-17Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-18Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-20Lacosamide Oral Solution20 mL in 1 CUP, UNIT-DOSESOLUTION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-427-05ML - Milliliter81033-4272d3d530a-15f2-4d4d-9e5d-f710122063ab12025-12-16
81033-427-10ML - Milliliter81033-427e7759c3a-f29e-436d-a32b-d8bc4391979412025-12-16
81033-427-14ML - Milliliter81033-42789afc664-5f8c-4f57-b098-6b73f9d090e012025-12-16
81033-427-15ML - Milliliter81033-427eb72a5ff-67c1-477c-aeda-b046b4c26a2a12026-03-17
81033-427-16ML - Milliliter81033-427b7dd91a8-307a-419e-ba67-9d10de53a4fc12025-12-16
81033-427-17ML - Milliliter81033-4275f9c12cb-f676-4679-9ec8-57f0c582724e12026-03-17
81033-427-18ML - Milliliter81033-42791e5225d-fa6e-4957-baa4-8e02b112b84712026-03-17
81033-427-20ML - Milliliter81033-4276d36b226-34e6-4c4e-a8c2-cf3af3bbebdc12026-03-17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 78 · 1,547 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
LacosamideLACOSAMIDEREMEDYREPACK INC.edd20b60-6265-4c4e-a95a-aaf8103cd8522026-07-21Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
LacosamideLACOSAMIDEFosun Pharma USAec1c5ddb-1143-7e6a-e053-2995a90a83822026-07-21Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LacosamideLACOSAMIDEGland Pharma Limited779d2381-f590-45f9-a191-f44af821f4c82026-07-14Warnings, Adverse reactionsExact identifier
unii: 563KS2PQY5
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.