Lacosamide

Product NDC
72603-305
11-digit product format
726030305
Labeler code
72603
Product ID
72603-305_e70388c9-39ef-4803-8a10-d46902a45462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA209224
Marketing category
ANDA
Marketing start
2024-06-01
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
Rxcui993856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-305-01Lacosamide200 mL in 1 BOTTLE, PLASTICSOLUTION2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-305-01ML - Milliliter72603-30514d9b716-9396-45b5-9743-356cc6f3cded12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-305LACOSAMIDE SOLUTION [NORTHSTAR RX LLC]2Current NDC, 1 package rows20241116_48fcaa27-baaa-446e-a282-0c3e232cd151.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN48fcaa27-baaa-446e-a282-0c3e232cd1512
993856lacosamide 10 MG/ML Oral SolutionSCD48fcaa27-baaa-446e-a282-0c3e232cd1512
993856lacosamide 10 MG per 1 ML Oral SolutionSY48fcaa27-baaa-446e-a282-0c3e232cd1512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-305-0172603030501200 mL in 1 BOTTLE, PLASTIC (72603-305-01) 200 ml2024-06-01NoNoCurrent