Lacosamide

Product NDC
70518-4562
11-digit product format
705184562
Labeler code
70518
Product ID
70518-4562_49ebae41-9193-beb3-e063-6294a90a24ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205237
Marketing category
ANDA
Marketing start
2026-02-02
Substance
LACOSAMIDE
Active strength
100 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
LACOSAMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809987

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
70518-4562-0Lacosamide30 in 1 BOXTABLET, FILM COATED301
70518-4562-1Lacosamide1 in 1 POUCHTABLET, FILM COATED11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN28a594e7-e89b-4d2c-b508-11a5f74700d31
809987lacosamide 100 MG Oral TabletSCD28a594e7-e89b-4d2c-b508-11a5f74700d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4562-07051845620030 POUCH in 1 BOX (70518-4562-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4562-1) 30 pouch2026-02-02NoNoCurrent
70518-4562-1705184562011 in 1 POUCHHistorical