LACOSAMIDE

Product NDC
58118-8812
11-digit product format
581188812
Labeler code
58118
Product ID
58118-8812_4dc9592a-e6a0-f95c-e063-6394a90a2f7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA204787
Marketing category
ANDA
Marketing start
2022-03-17
Substance
LACOSAMIDE
Active strength
50 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LACOSAMIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809987, 809992, 809996, 810000

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
58118-8812-8LACOSAMIDE30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
809992lacosamide 150 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
809996lacosamide 200 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
810000lacosamide 50 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
809987lacosamide 100 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1
809992lacosamide 150 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1
809996lacosamide 200 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1
810000lacosamide 50 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58118-8812-85811888120830 TABLET, FILM COATED in 1 BLISTER PACK (58118-8812-8) 2026-03-24NoNoCurrent