Lacosamide

Product NDC
70518-4504
11-digit product format
705184504
Labeler code
70518
Product ID
70518-4504_49ebe440-0aef-da54-e063-6294a90a41cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204974
Marketing category
ANDA
Marketing start
2025-10-14
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
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
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
70518-4504-0Lacosamide30 in 1 BLISTER PACKTABLET, FILM COATED302
70518-4504-1Lacosamide30 in 1 BOXTABLET, FILM COATED302
70518-4504-2Lacosamide1 in 1 POUCHTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809996lacosamide 200 MG Oral TabletPSNedd20b60-6265-4c4e-a95a-aaf8103cd8522
809996lacosamide 200 MG Oral TabletSCDedd20b60-6265-4c4e-a95a-aaf8103cd8522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4504-07051845040030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4504-0) 2025-10-14NoNoHistorical
70518-4504-17051845040130 POUCH in 1 BOX (70518-4504-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4504-2) 30 pouch2026-02-02NoNoHistorical
70518-4504-2705184504021 in 1 POUCHHistorical