FDA.reportPublic FDA data

Lacosamide

Product NDC
72266-242
11-digit product format
722660242
Labeler code
72266
Product ID
72266-242_1ddb7a71-0e47-2c7a-e063-6394a90a98b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA
Application
ANDA215628
Marketing category
ANDA
Marketing start
2022-11-15
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
72266-242-01Lacosamide20 mL in 1 VIAL, SINGLE-DOSEINJECTION206
72266-242-05Lacosamide5 in 1 CARTONINJECTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-242-01ML - Milliliter72266-242abcc6381-1019-44db-8790-e1c14e6bf13f12023-02-06
72266-242-05ML - Milliliter72266-24266265ff1-ed91-43f5-a01c-4852b6d5074112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-242LACOSAMIDE INJECTION [FOSUN PHARMA USA]6Current NDC, Legacy NDC, 2 package rows20250323_ec1c5ddb-1143-7e6a-e053-2995a90a8382.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNec1c5ddb-1143-7e6a-e053-2995a90a83826
80997420 ML lacosamide 10 MG/ML InjectionSCDec1c5ddb-1143-7e6a-e053-2995a90a83826
809974lacosamide 200 MG per 20 ML InjectionSYec1c5ddb-1143-7e6a-e053-2995a90a83826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-242-017226602420120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
72266-242-05722660242055 VIAL, SINGLE-DOSE in 1 CARTON (72266-242-05) / 20 mL in 1 VIAL, SINGLE-DOSE (72266-242-01) 2022-11-150000-00-00NoNoCurrent