Lacosamide

Product NDC
72205-220
11-digit product format
722050220
Labeler code
72205
Product ID
72205-220_b63d4a4a-6d25-4a28-b870-430043ed6c1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215979
Marketing category
ANDA
Marketing start
2023-02-09
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
72205-220-01Lacosamide20 mL in 1 VIALINJECTION202
72205-220-07Lacosamide10 in 1 CARTONINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-220LACOSAMIDE INJECTION [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, 2 package rows20250120_a024081a-e131-4e88-967d-40155651a945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNa024081a-e131-4e88-967d-40155651a9452
80997420 ML lacosamide 10 MG/ML InjectionSCDa024081a-e131-4e88-967d-40155651a9452
809974lacosamide 200 MG per 20 ML InjectionSYa024081a-e131-4e88-967d-40155651a9452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-220-017220502200120 mL in 1 VIAL20 mlHistorical
72205-220-077220502200710 VIAL in 1 CARTON (72205-220-07) / 20 mL in 1 VIAL (72205-220-01) 10 vial2023-05-23NoNoCurrent