FDA.reportPublic FDA data

Lacosamide

Product NDC
69315-318
11-digit product format
693150318
Labeler code
69315
Product ID
69315-318_0267a67e-d492-480b-a688-e2cec27142a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA216461
Marketing category
ANDA
Marketing start
2023-02-06
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-318-20Lacosamide200 mL in 1 BOTTLE, PLASTICSOLUTION2006
69315-318-46Lacosamide465 mL in 1 BOTTLE, PLASTICSOLUTION4656

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-318-20ML - Milliliter69315-318533b9e40-e3cc-4d84-a929-6db01049b40412023-09-05
69315-318-46ML - Milliliter69315-318651b1943-7c3f-4950-9186-156cea9971c112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-318LACOSAMIDE SOLUTION [LEADING PHARMA, LLC]6Current NDC, 2 package rows20241207_45786c84-51ef-4440-bc88-2501951e4c41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN45786c84-51ef-4440-bc88-2501951e4c416
993856lacosamide 10 MG/ML Oral SolutionSCD45786c84-51ef-4440-bc88-2501951e4c416
993856lacosamide 10 MG per 1 ML Oral SolutionSY45786c84-51ef-4440-bc88-2501951e4c416
993856lacosamide 10 MG in 1 mL Oral SolutionPSNfe24b28b-ca15-4dfd-a198-53cdc2c8cb991
993856lacosamide 10 MG/ML Oral SolutionSCDfe24b28b-ca15-4dfd-a198-53cdc2c8cb991
993856lacosamide 10 MG per 1 ML Oral SolutionSYfe24b28b-ca15-4dfd-a198-53cdc2c8cb991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69315-318-2069315031820200 mL in 1 BOTTLE, PLASTIC (69315-318-20) 200 ml2023-07-25NoNoCurrent
69315-318-4669315031846465 mL in 1 BOTTLE, PLASTIC (69315-318-46) 465 ml2023-07-25NoNoCurrent