FDA.reportPublic FDA data

Lacosamide Oral Solution

Product NDC
62135-885
11-digit product format
621350885
Labeler code
62135
Product ID
62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA215154
Marketing category
ANDA
Marketing start
2024-05-15
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 Oral Solution
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
62135-885-05Lacosamide Oral Solution5 mL in 1 CUPSOLUTION52
62135-885-10Lacosamide Oral Solution10 mL in 1 CUPSOLUTION102
62135-885-22Lacosamide Oral Solution200 mL in 1 BOTTLESOLUTION2002
62135-885-23Lacosamide Oral Solution10 in 1 TRAYSOLUTION102
62135-885-23Lacosamide Oral Solution2 in 1 BOXSOLUTION22
62135-885-24Lacosamide Oral Solution10 in 1 TRAYSOLUTION102
62135-885-24Lacosamide Oral Solution2 in 1 BOXSOLUTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-885-05ML - Milliliter62135-8855f9b4334-8b4a-432f-b122-57024a0c475512025-03-04
62135-885-10ML - Milliliter62135-88552b88e84-adf5-4e16-995e-403de4ba357812025-03-04
62135-885-22ML - Milliliter62135-885b5c7a749-7308-4f27-aeb8-9896f772fae812025-03-04
62135-885-23ML - Milliliter62135-885072759b1-b7f3-4f10-a2d4-ff5791bfe8b012025-03-04
62135-885-24ML - Milliliter62135-8850c3ba2e0-f4c6-482f-a21e-112551a81e6912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-885LACOSAMIDE ORAL SOLUTION (LACOSAMIDE) SOLUTION [CHARTWELL RX, LLC]2Current NDC, 7 package rows20250215_7197c0b6-5bb9-43b3-be1d-e7615629df9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN7197c0b6-5bb9-43b3-be1d-e7615629df9a2
993856lacosamide 10 MG/ML Oral SolutionSCD7197c0b6-5bb9-43b3-be1d-e7615629df9a2
993856lacosamide 10 MG per 1 ML Oral SolutionSY7197c0b6-5bb9-43b3-be1d-e7615629df9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-885-05621350885055 mL in 1 CUP5 mlHistorical
62135-885-106213508851010 mL in 1 CUP10 mlHistorical
62135-885-2262135088522200 mL in 1 BOTTLE (62135-885-22) 200 ml2024-11-27NoNoCurrent
62135-885-23621350885232 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10) 2 tray2025-02-10NoNoCurrent
62135-885-24621350885242 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05) 2 tray2025-02-10NoNoCurrent