Lacosamide

Product NDC
13811-207
11-digit product format
138110207
Labeler code
13811
Product ID
13811-207_bebad518-a888-4d46-b575-ea2460f93996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Trigen Laboratories, LLC
Application
ANDA218464
Marketing category
ANDA
Marketing start
2025-06-30
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
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
13811-207-40Lacosamide10 in 1 CARTONINJECTION102
13811-207-74Lacosamide20 mL in 1 VIAL, GLASSINJECTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-207-40ML - Milliliter13811-2077d7408be-61d3-4f2f-9403-56c79ae09ec512025-08-11
13811-207-74ML - Milliliter13811-207c766d220-ee9e-4125-8e66-5601c223dd9d12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNd98ec7ed-353f-4d4f-9ccd-57ddc62edd0d2
80997420 ML lacosamide 10 MG/ML InjectionSCDd98ec7ed-353f-4d4f-9ccd-57ddc62edd0d2
809974lacosamide 200 MG per 20 ML InjectionSYd98ec7ed-353f-4d4f-9ccd-57ddc62edd0d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13811-207-401381102074010 VIAL, GLASS in 1 CARTON (13811-207-40) / 20 mL in 1 VIAL, GLASS (13811-207-74) 2025-06-30NoNoHistorical
13811-207-741381102077420 mL in 1 VIAL, GLASS20 mlHistorical