FDA.reportPublic FDA data

Lacosamide

Product NDC
65219-204
11-digit product format
652190204
Labeler code
65219
Product ID
65219-204_0f09367f-3191-41f4-891c-abdd7ed3cecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA214677
Marketing category
ANDA
Marketing start
2022-07-25
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
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
LACOSAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809974

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
65219-204-01Lacosamide20 mL in 1 VIAL, SINGLE-DOSEINJECTION203
65219-204-20Lacosamide10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-204-01ML - Milliliter65219-2044f2ff632-391b-4f63-8aba-046fc588548b12022-12-07
65219-204-20ML - Milliliter65219-2043ba689d5-87ea-44e8-93b3-7c845b85d4f912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-204LACOSAMIDE INJECTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20250215_419ff519-2b19-4fb9-adfa-868ba0229407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSN419ff519-2b19-4fb9-adfa-868ba02294073
80997420 ML lacosamide 10 MG/ML InjectionSCD419ff519-2b19-4fb9-adfa-868ba02294073
809974lacosamide 200 MG per 20 ML InjectionSY419ff519-2b19-4fb9-adfa-868ba02294073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-204-016521902040120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
65219-204-206521902042010 VIAL, SINGLE-DOSE in 1 CARTON (65219-204-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-204-01) 2022-07-250000-00-00NoNoCurrent