Lacosamide Oral Solution

Product NDC
71921-411
11-digit product format
719210411
Labeler code
71921
Product ID
71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA220386
Marketing category
ANDA
Marketing start
2026-01-30
Substance
LACOSAMIDE
Active strength
10 mg/mL
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
Lacosamide Oral Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE10 mg/mL

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
71921-411-71Lacosamide Oral Solution200 mL in 1 BOTTLESOLUTION2002
71921-411-71Lacosamide Oral Solution1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-411-71ML - Milliliter71921-411d9d00c31-bdff-4deb-bf4c-7c3a0e98dc6512026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSNba4e2e28-7dc3-47b3-9c2c-34e0b1f39fb82
993856lacosamide 10 MG/ML Oral SolutionSCDba4e2e28-7dc3-47b3-9c2c-34e0b1f39fb82
993856lacosamide 10 MG per 1 ML Oral SolutionSYba4e2e28-7dc3-47b3-9c2c-34e0b1f39fb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-411-71719210411711 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE1 bottle2026-01-30NoNoHistorical