LACOSAMIDE

Product NDC
67046-1445
11-digit product format
670461445
Labeler code
67046
Product ID
67046-1445_2e969590-2f07-e068-e063-6294a90ab749
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA204787
Marketing category
ANDA
Marketing start
2025-02-07
Substance
LACOSAMIDE
Active strength
200 mg/1
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
LACOSAMIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809996

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
67046-1445-3LACOSAMIDE30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1445LACOSAMIDE TABLET, FILM COATED [COUPLER LLC]2Current NDC, 1 package rows20250223_2d999f1f-11c6-bc28-e063-6394a90a4a52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809996lacosamide 200 MG Oral TabletPSN2d999f1f-11c6-bc28-e063-6394a90a4a522
809996lacosamide 200 MG Oral TabletSCD2d999f1f-11c6-bc28-e063-6394a90a4a522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1445-36704614450330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1445-3) 2025-02-07NoNoHistorical