Lacosamide

Product NDC
31722-627
11-digit product format
317220627
Labeler code
31722
Product ID
31722-627_3feb1c1a-c299-1862-e063-6394a90af07e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA209301
Marketing category
ANDA
Marketing start
2022-05-31
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
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
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
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-627-26Lacosamide1 in 1 CARTONSOLUTION15
31722-627-26Lacosamide200 mL in 1 BOTTLESOLUTION2005
31722-627-46Lacosamide465 mL in 1 BOTTLESOLUTION4655
31722-627-46Lacosamide1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-627-26ML - Milliliter31722-62714e58f86-18ab-4b0e-9b7b-791bf0125b3812022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-627LACOSAMIDE (LACOSAMIDE) SOLUTION [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20250319_bbd80370-3d23-41f8-8914-c6ea897c0154.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN75de00d8-d2e7-4025-be4e-f49299068e7e22
993856lacosamide 10 MG/ML Oral SolutionSCD75de00d8-d2e7-4025-be4e-f49299068e7e22
993856lacosamide 10 MG per 1 ML Oral SolutionSY75de00d8-d2e7-4025-be4e-f49299068e7e22
993856lacosamide 10 MG in 1 mL Oral SolutionPSNbbd80370-3d23-41f8-8914-c6ea897c01545
993856lacosamide 10 MG/ML Oral SolutionSCDbbd80370-3d23-41f8-8914-c6ea897c01545
993856lacosamide 10 MG per 1 ML Oral SolutionSYbbd80370-3d23-41f8-8914-c6ea897c01545

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-627-26317220627261 BOTTLE in 1 CARTON (31722-627-26) / 200 mL in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
31722-627-46317220627461 BOTTLE in 1 CARTON (31722-627-46) / 465 mL in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent