FDA.reportPublic FDA data

Vimpat

Product NDC
0131-2478
11-digit product format
001312478
Labeler code
0131
Product ID
0131-2478_51a12988-3e4b-c52b-e063-6394a90a7415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
UCB, Inc.
Application
NDA022253
Marketing category
NDA
Marketing start
2009-05-26
Substance
LACOSAMIDE
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vimpat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809974, 809984, 809987, 809990, 809992, 809994, 809996, 809998, 810000, 810002, 993856, 995156

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0131-2478-35Vimpat60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6063
0131-2478-60Vimpat6 in 1 CARTONTABLET, FILM COATED663
0131-2478-60Vimpat10 in 1 BLISTER PACKTABLET, FILM COATED1063
0131-2478-99Vimpat1 in 1 CARTONTABLET, FILM COATED163
0131-2478-99Vimpat14 in 1 BLISTER PACKTABLET, FILM COATED1463

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0131-2478-35EA - Each0131-2478a30cdeb9-9c2b-4989-96aa-d3a837cb1fd512012-07-24
0131-2478-60EA - Each0131-2478d20b2ea7-652d-4117-93c3-24b9c829c6cc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lacosamideACTIVE INGREDIENT563KS2PQY5VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
lacosamideACTIVE MOIETY563KS2PQY5VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
aluminum oxideINACTIVE INGREDIENTLMI26O6933VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
aspartameINACTIVE INGREDIENTZ0H242BBR1VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
carboxymethylcellulose sodium, unspecified formINACTIVE INGREDIENTK679OBS311VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
crospovidoneINACTIVE INGREDIENT68401960MKVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
fd&c blue no. 2INACTIVE INGREDIENTL06K8R7DQKVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
ferric oxide redINACTIVE INGREDIENT1K09F3G675VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
glycerinINACTIVE INGREDIENTPDC6A3C0OXVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
hydrochloric acidINACTIVE INGREDIENTQTT17582CBVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
hypromellosesINACTIVE INGREDIENT3NXW29V3WOVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
indigotindisulfonate sodiumINACTIVE INGREDIENTD3741U8K7LVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
magnesium stearateINACTIVE INGREDIENT70097M6I30VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
maltolINACTIVE INGREDIENT3A9RD92BS4VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
methylparabenINACTIVE INGREDIENTA2I8C7HI9TVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
polyvinyl alcoholINACTIVE INGREDIENT532B59J990VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
propylene glycolINACTIVE INGREDIENT6DC9Q167V3VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
sodium chlorideINACTIVE INGREDIENT451W47IQ8XVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
sorbitolINACTIVE INGREDIENT506T60A25RVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
talcINACTIVE INGREDIENT7SEV7J4R1UVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26
waterINACTIVE INGREDIENT059QF0KO0RVIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) KIT VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0131-2478VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.]59Current NDC, Legacy NDC, 5 package rows20240925_9e79b42c-38a3-4b2c-a196-a5a1948250e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809987lacosamide 100 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809992lacosamide 150 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809974lacosamide 200 MG in 20 ML InjectionPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809996lacosamide 200 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
810000lacosamide 50 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
995156VIMPAT 10 MG in 1 mL Oral SolutionPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809990VIMPAT 100 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809994VIMPAT 150 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809984VIMPAT 200 MG in 20 ML InjectionPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
809998VIMPAT 200 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
810002VIMPAT 50 MG Oral TabletPSN9e79b42c-38a3-4b2c-a196-a5a1948250e263
80998420 ML lacosamide 10 MG/ML Injection [Vimpat]SBD9e79b42c-38a3-4b2c-a196-a5a1948250e263
995156lacosamide 10 MG/ML Oral Solution [Vimpat]SBD9e79b42c-38a3-4b2c-a196-a5a1948250e263
809990lacosamide 100 MG Oral Tablet [Vimpat]SBD9e79b42c-38a3-4b2c-a196-a5a1948250e263
809994lacosamide 150 MG Oral Tablet [Vimpat]SBD9e79b42c-38a3-4b2c-a196-a5a1948250e263
809998lacosamide 200 MG Oral Tablet [Vimpat]SBD9e79b42c-38a3-4b2c-a196-a5a1948250e263
810002lacosamide 50 MG Oral Tablet [Vimpat]SBD9e79b42c-38a3-4b2c-a196-a5a1948250e263
80997420 ML lacosamide 10 MG/ML InjectionSCD9e79b42c-38a3-4b2c-a196-a5a1948250e263
993856lacosamide 10 MG/ML Oral SolutionSCD9e79b42c-38a3-4b2c-a196-a5a1948250e263
809987lacosamide 100 MG Oral TabletSCD9e79b42c-38a3-4b2c-a196-a5a1948250e263
809992lacosamide 150 MG Oral TabletSCD9e79b42c-38a3-4b2c-a196-a5a1948250e263
809996lacosamide 200 MG Oral TabletSCD9e79b42c-38a3-4b2c-a196-a5a1948250e263
810000lacosamide 50 MG Oral TabletSCD9e79b42c-38a3-4b2c-a196-a5a1948250e263
80998420 ML Vimpat 10 MG/ML InjectionSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
993856lacosamide 10 MG per 1 ML Oral SolutionSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
809974lacosamide 200 MG per 20 ML InjectionSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
995156Vimpat 10 MG per 1 ML Oral SolutionSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
995156Vimpat 10 MG/ML Oral SolutionSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
809990Vimpat 100 MG Oral TabletSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
809994Vimpat 150 MG Oral TabletSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
809998Vimpat 200 MG Oral TabletSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
809984Vimpat 200 MG per 20 ML InjectionSY9e79b42c-38a3-4b2c-a196-a5a1948250e263
810002Vimpat 50 MG Oral TabletSY9e79b42c-38a3-4b2c-a196-a5a1948250e263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0131-2478-350013124783560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0131-2478-35) 2009-05-260000-00-00NoNoCurrent
0131-2478-60001312478606 BLISTER PACK in 1 CARTON (0131-2478-60) / 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2009-05-260000-00-00NoNoCurrent
0131-2478-99001312478991 BLISTER PACK in 1 CARTON (0131-2478-99) / 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2009-05-260000-00-00NoNoCurrent