Lacosamide

Product NDC
16714-548
11-digit product format
167140548
Labeler code
16714
Product ID
16714-548_ad8753cb-70b7-431e-9d52-93558d469ef5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA208308
Marketing category
ANDA
Marketing start
2022-08-01
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
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-548-01Lacosamide60 in 1 BOTTLETABLET608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-548LACOSAMIDE TABLET [NORTHSTAR RXLLC]6Current NDC, Legacy NDC, 1 package rows20250125_9dffda6c-9e44-478f-9e02-9da3ab4c50e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN9dffda6c-9e44-478f-9e02-9da3ab4c50e18
809992lacosamide 150 MG Oral TabletPSN9dffda6c-9e44-478f-9e02-9da3ab4c50e18
809996lacosamide 200 MG Oral TabletPSN9dffda6c-9e44-478f-9e02-9da3ab4c50e18
810000lacosamide 50 MG Oral TabletPSN9dffda6c-9e44-478f-9e02-9da3ab4c50e18
809987lacosamide 100 MG Oral TabletSCD9dffda6c-9e44-478f-9e02-9da3ab4c50e18
809992lacosamide 150 MG Oral TabletSCD9dffda6c-9e44-478f-9e02-9da3ab4c50e18
809996lacosamide 200 MG Oral TabletSCD9dffda6c-9e44-478f-9e02-9da3ab4c50e18
810000lacosamide 50 MG Oral TabletSCD9dffda6c-9e44-478f-9e02-9da3ab4c50e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-548-011671405480160 TABLET in 1 BOTTLE (16714-548-01) 60 tablet2022-08-010000-00-00NoNoCurrent