FDA.reportPublic FDA data

LACOSAMIDE

Product NDC
51991-350
11-digit product format
519910350
Labeler code
51991
Product ID
51991-350_d59d1657-c847-475f-998d-49d186f6697e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA204921
Marketing category
ANDA
Marketing start
2022-03-18
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
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-350-05LACOSAMIDE500 in 1 BOTTLETABLET, FILM COATED50016
51991-350-06LACOSAMIDE60 in 1 BOTTLETABLET, FILM COATED6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-350-05EA - Each51991-35066574f72-202c-4e88-adaa-d29950d257b512022-05-04
51991-350-06EA - Each51991-3500b16e718-8ecc-4302-bff4-9f7db592072412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-350LACOSAMIDE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]16Current NDC, Legacy NDC, 2 package rows20250110_f7ea3ce6-4ca7-4405-a011-48e7d71360a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSNf7ea3ce6-4ca7-4405-a011-48e7d71360a516
809992lacosamide 150 MG Oral TabletPSNf7ea3ce6-4ca7-4405-a011-48e7d71360a516
809996lacosamide 200 MG Oral TabletPSNf7ea3ce6-4ca7-4405-a011-48e7d71360a516
810000lacosamide 50 MG Oral TabletPSNf7ea3ce6-4ca7-4405-a011-48e7d71360a516
809987lacosamide 100 MG Oral TabletSCDf7ea3ce6-4ca7-4405-a011-48e7d71360a516
809992lacosamide 150 MG Oral TabletSCDf7ea3ce6-4ca7-4405-a011-48e7d71360a516
809996lacosamide 200 MG Oral TabletSCDf7ea3ce6-4ca7-4405-a011-48e7d71360a516
810000lacosamide 50 MG Oral TabletSCDf7ea3ce6-4ca7-4405-a011-48e7d71360a516
809987lacosamide 100 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
809992lacosamide 150 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
809996lacosamide 200 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
810000lacosamide 50 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
809987lacosamide 100 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295
809992lacosamide 150 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295
809996lacosamide 200 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295
810000lacosamide 50 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-350-0551991035005500 TABLET, FILM COATED in 1 BOTTLE (51991-350-05) 2022-03-180000-00-00NoNoCurrent
51991-350-065199103500660 TABLET, FILM COATED in 1 BOTTLE (51991-350-06) 2022-03-180000-00-00NoNoCurrent