Lacosamide

Product NDC
85742-009
11-digit product format
857420009
Labeler code
85742
Product ID
85742-009_9e55b694-312b-480c-a20f-a6ed325906d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kanchan Healthcare Inc
Application
ANDA218014
Marketing category
ANDA
Marketing start
2025-07-01
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
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
LACOSAMIDE100 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85742-009-07Lacosamide6 in 1 CARTONTABLET, FILM COATED61
85742-009-07Lacosamide10 in 1 BLISTER PACKTABLET, FILM COATED101
85742-009-08Lacosamide60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
809992lacosamide 150 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
809996lacosamide 200 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
810000lacosamide 50 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
809987lacosamide 100 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71
809992lacosamide 150 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71
809996lacosamide 200 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71
810000lacosamide 50 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85742-009-07857420009076 BLISTER PACK in 1 CARTON (85742-009-07) / 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2025-08-06NoNoCurrent
85742-009-088574200090860 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85742-009-08) 2025-08-06NoNoCurrent