FDA.reportPublic FDA data

Lacosamide

Product NDC
33342-303
11-digit product format
333420303
Labeler code
33342
Product ID
33342-303_035d85e5-8688-4390-bd55-74baa91c0e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA208466
Marketing category
ANDA
Marketing start
2024-05-24
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
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-303-09Lacosamide60 in 1 BOTTLETABLET, FILM COATED601
33342-303-11Lacosamide100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-303-09EA - Each33342-3030a1b6382-b4f8-46a0-92e7-9b3fd419df0912025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-303LACOSAMIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20240612_035d85e5-8688-4390-bd55-74baa91c0e9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN035d85e5-8688-4390-bd55-74baa91c0e9d1
809992lacosamide 150 MG Oral TabletPSN035d85e5-8688-4390-bd55-74baa91c0e9d1
809996lacosamide 200 MG Oral TabletPSN035d85e5-8688-4390-bd55-74baa91c0e9d1
810000lacosamide 50 MG Oral TabletPSN035d85e5-8688-4390-bd55-74baa91c0e9d1
809987lacosamide 100 MG Oral TabletSCD035d85e5-8688-4390-bd55-74baa91c0e9d1
809992lacosamide 150 MG Oral TabletSCD035d85e5-8688-4390-bd55-74baa91c0e9d1
809996lacosamide 200 MG Oral TabletSCD035d85e5-8688-4390-bd55-74baa91c0e9d1
810000lacosamide 50 MG Oral TabletSCD035d85e5-8688-4390-bd55-74baa91c0e9d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-303-093334203030960 TABLET, FILM COATED in 1 BOTTLE (33342-303-09) 2024-05-24NoNoHistorical
33342-303-1133342030311100 TABLET, FILM COATED in 1 BOTTLE (33342-303-11) 2024-05-24NoNoHistorical