FDA.reportPublic FDA data

Lacosamide

Product NDC
0904-7463
11-digit product format
009047463
Labeler code
0904
Product ID
0904-7463_6e6658af-c86d-4c22-8bd1-3c36e7cece85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA216151
Marketing category
ANDA
Marketing start
2023-04-28
Substance
LACOSAMIDE
Active strength
50 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lacosamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui993856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7463-41Lacosamide5 mL in 1 CUP, UNIT-DOSESOLUTION516
0904-7463-68Lacosamide10 in 1 TRAYSOLUTION1016
0904-7463-68Lacosamide1 in 1 CASESOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7463-41ML - Milliliter0904-74631d325330-5072-4df5-ad2d-68e847cb6b5712024-08-12
0904-7463-68ML - Milliliter0904-7463bbb0b911-fa09-4c9a-a9bc-829f364dd76d12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7463LACOSAMIDE SOLUTION [MAJOR PHARMACEUTICALS]14Current NDC, 3 package rows20250130_973cea8d-e516-4014-a116-c5990554a550.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN973cea8d-e516-4014-a116-c5990554a55016
993856lacosamide 10 MG/ML Oral SolutionSCD973cea8d-e516-4014-a116-c5990554a55016
993856lacosamide 10 MG per 1 ML Oral SolutionSY973cea8d-e516-4014-a116-c5990554a55016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7463-41009047463415 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0904-7463-68009047463681 TRAY in 1 CASE (0904-7463-68) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7463-41) 1 tray2023-04-28NoNoCurrent