Lacosamide

Product NDC
71921-220
11-digit product format
719210220
Labeler code
71921
Product ID
71921-220_85fd1828-d3d9-4b4b-965b-7ed7ef5f5e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA208308
Marketing category
ANDA
Marketing start
2023-09-21
Substance
LACOSAMIDE
Active strength
50 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
LACOSAMIDE50 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71921-220-06Lacosamide60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-220-06EA - Each71921-2203e20ba29-0f5f-4319-bffa-82314822306012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-220LACOSAMIDE TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]5Current NDC, 1 package rows20250214_3680c0ff-7f5c-4572-b1eb-4fea96b7fbe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
809992lacosamide 150 MG Oral TabletPSN3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
809996lacosamide 200 MG Oral TabletPSN3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
810000lacosamide 50 MG Oral TabletPSN3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
809987lacosamide 100 MG Oral TabletSCD3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
809992lacosamide 150 MG Oral TabletSCD3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
809996lacosamide 200 MG Oral TabletSCD3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25
810000lacosamide 50 MG Oral TabletSCD3680c0ff-7f5c-4572-b1eb-4fea96b7fbe25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-220-067192102200660 TABLET in 1 BOTTLE (71921-220-06) 60 tablet2023-09-21NoNoHistorical