Lacosamide

Product NDC
68462-940
11-digit product format
684620940
Labeler code
68462
Product ID
68462-940_887e8e82-ff05-445b-aaa3-d9fe1590a258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Glenmark Pharmaceuticals Limited
Application
ANDA215379
Marketing category
ANDA
Marketing start
2024-09-30
Substance
LACOSAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lacosamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui993856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-940-86Lacosamide200 mL in 1 BOTTLE, PLASTICSOLUTION2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-940-86ML - Milliliter68462-9405a2d7e11-7702-4a4a-9584-b963856d758a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-940LACOSAMIDE SOLUTION [GLENMARK PHARMACEUTICALS LIMITED]1Current NDC, 1 package rows20241127_458e80da-8fc1-4715-9b4b-bc4f388f933f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN458e80da-8fc1-4715-9b4b-bc4f388f933f2
993856lacosamide 10 MG/ML Oral SolutionSCD458e80da-8fc1-4715-9b4b-bc4f388f933f2
993856lacosamide 10 MG per 1 ML Oral SolutionSY458e80da-8fc1-4715-9b4b-bc4f388f933f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-940-8668462094086200 mL in 1 BOTTLE, PLASTIC (68462-940-86) 200 ml2024-09-30NoNoCurrent