Lacosamide

Product NDC
14445-406
11-digit product format
144450406
Labeler code
14445
Product ID
14445-406_080b7b57-d72a-4306-993e-81ac0278ab5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Indoco Remedies Limited
Application
ANDA214301
Marketing category
ANDA
Marketing start
2022-04-09
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
14445-406-20Lacosamide20 mL in 1 VIAL, GLASSINJECTION2011
14445-406-20Lacosamide10 in 1 CARTONINJECTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-406LACOSAMIDE INJECTION [INDOCO REMEDIES LIMITED ]11Current NDC, Legacy NDC, 2 package rows20240328_ba337b2c-7c1f-4f7b-ba93-054f502400f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNba337b2c-7c1f-4f7b-ba93-054f502400f311
80997420 ML lacosamide 10 MG/ML InjectionSCDba337b2c-7c1f-4f7b-ba93-054f502400f311
809974lacosamide 200 MG per 20 ML InjectionSYba337b2c-7c1f-4f7b-ba93-054f502400f311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14445-406-201444504062010 VIAL, GLASS in 1 CARTON (14445-406-20) / 20 mL in 1 VIAL, GLASS2022-04-090000-00-00NoNoCurrent