Lacosamide

Product NDC
67877-735
11-digit product format
678770735
Labeler code
67877
Product ID
67877-735_062a789f-52f0-482b-9ec0-2ba3ac1572ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA214695
Marketing category
ANDA
Marketing start
2022-04-01
Substance
LACOSAMIDE
Active strength
150 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
LACOSAMIDE150 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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
67877-735-05Lacosamide500 in 1 BOTTLETABLET, FILM COATED50019
67877-735-31Lacosamide10 in 1 BLISTER PACKTABLET, FILM COATED1019
67877-735-31Lacosamide6 in 1 CARTONTABLET, FILM COATED619
67877-735-60Lacosamide60 in 1 BOTTLETABLET, FILM COATED6019
67877-735-90Lacosamide90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-735-60EA - Each67877-7356dd5ff2c-41ac-4c01-8f31-0616c8dc0d3512022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-735LACOSAMIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]18Current NDC, Legacy NDC, 5 package rows20240704_9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
809992lacosamide 150 MG Oral TabletPSN9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
809996lacosamide 200 MG Oral TabletPSN9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
810000lacosamide 50 MG Oral TabletPSN9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
809987lacosamide 100 MG Oral TabletSCD9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
809992lacosamide 150 MG Oral TabletSCD9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
809996lacosamide 200 MG Oral TabletSCD9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
810000lacosamide 50 MG Oral TabletSCD9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de19
809987lacosamide 100 MG Oral TabletPSNc83d2156-4dde-4316-98f1-b3dc751f3eac4
809992lacosamide 150 MG Oral TabletPSNc83d2156-4dde-4316-98f1-b3dc751f3eac4
809996lacosamide 200 MG Oral TabletPSNc83d2156-4dde-4316-98f1-b3dc751f3eac4
810000lacosamide 50 MG Oral TabletPSNc83d2156-4dde-4316-98f1-b3dc751f3eac4
809987lacosamide 100 MG Oral TabletSCDc83d2156-4dde-4316-98f1-b3dc751f3eac4
809992lacosamide 150 MG Oral TabletSCDc83d2156-4dde-4316-98f1-b3dc751f3eac4
809996lacosamide 200 MG Oral TabletSCDc83d2156-4dde-4316-98f1-b3dc751f3eac4
810000lacosamide 50 MG Oral TabletSCDc83d2156-4dde-4316-98f1-b3dc751f3eac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-735-0567877073505500 TABLET, FILM COATED in 1 BOTTLE (67877-735-05) 2022-04-010000-00-00NoNoCurrent
67877-735-31678770735316 BLISTER PACK in 1 CARTON (67877-735-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2022-04-010000-00-00NoNoCurrent
67877-735-606787707356060 TABLET, FILM COATED in 1 BOTTLE (67877-735-60) 2022-04-010000-00-00NoNoCurrent
67877-735-906787707359090 TABLET, FILM COATED in 1 BOTTLE (67877-735-90) 2022-04-010000-00-00NoNoCurrent