FDA.reportPublic FDA data

Lacosamide

Product NDC
59651-016
11-digit product format
596510016
Labeler code
59651
Product ID
59651-016_3b9722c2-c742-4617-9832-672dd8a3ce0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209224
Marketing category
ANDA
Marketing start
2024-01-24
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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-016-02Lacosamide200 mL in 1 BOTTLE, PLASTICSOLUTION2003
59651-016-46Lacosamide465 mL in 1 BOTTLE, PLASTICSOLUTION4653

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-016LACOSAMIDE SOLUTION [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20241019_614490ce-a62c-4222-8e4b-ce802cf63028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN614490ce-a62c-4222-8e4b-ce802cf630283
993856lacosamide 10 MG/ML Oral SolutionSCD614490ce-a62c-4222-8e4b-ce802cf630283
993856lacosamide 10 MG per 1 ML Oral SolutionSY614490ce-a62c-4222-8e4b-ce802cf630283
993856lacosamide 10 MG in 1 mL Oral SolutionPSNf9aa6154-5d80-4597-90c3-cec131b455d42
993856lacosamide 10 MG/ML Oral SolutionSCDf9aa6154-5d80-4597-90c3-cec131b455d42
993856lacosamide 10 MG per 1 ML Oral SolutionSYf9aa6154-5d80-4597-90c3-cec131b455d42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-016-0259651001602200 mL in 1 BOTTLE, PLASTIC (59651-016-02) 200 ml2024-01-24NoNoCurrent
59651-016-4659651001646465 mL in 1 BOTTLE, PLASTIC (59651-016-46) 465 ml2024-01-24NoNoCurrent