FDA.reportPublic FDA data

Lacosamide

Product NDC
0904-7246
11-digit product format
009047246
Labeler code
0904
Product ID
0904-7246_2ced4e9b-b558-4534-bb96-99da562710a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
0904-7246-68Lacosamide1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7246-68Lacosamide60 in 1 CARTONTABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7246-68EA - Each0904-724619afaa60-60a7-4e61-b156-1f311479c16f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7246LACOSAMIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20241012_c83d2156-4dde-4316-98f1-b3dc751f3eac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
0904-7246-680090472466860 BLISTER PACK in 1 CARTON (0904-7246-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK60 blister pack2022-04-010000-00-00NoNoCurrent