FDA.reportPublic FDA data

Lacosamide Oral Solution

Product NDC
68999-885
11-digit product format
689990885
Labeler code
68999
Product ID
68999-885_4ba97913-d84d-a2c3-e063-6394a90a2363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lacosamide Oral Solution
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
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-885-05Lacosamide Oral Solution5 mL in 1 CUPSOLUTION52
68999-885-10Lacosamide Oral Solution10 mL in 1 CUPSOLUTION102
68999-885-23Lacosamide Oral Solution2 in 1 BOXSOLUTION22
68999-885-23Lacosamide Oral Solution10 in 1 TRAYSOLUTION102
68999-885-24Lacosamide Oral Solution10 in 1 TRAYSOLUTION102
68999-885-24Lacosamide Oral Solution2 in 1 BOXSOLUTION22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSNe265fd09-8149-4423-a317-5760d34b8e9b2
993856lacosamide 10 MG/ML Oral SolutionSCDe265fd09-8149-4423-a317-5760d34b8e9b2
993856lacosamide 10 MG per 1 ML Oral SolutionSYe265fd09-8149-4423-a317-5760d34b8e9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-885-05689990885055 mL in 1 CUP5 mlHistorical
68999-885-106899908851010 mL in 1 CUP10 mlHistorical
68999-885-23689990885232 TRAY in 1 BOX (68999-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10) 2 tray2026-01-14NoNoHistorical
68999-885-24689990885242 TRAY in 1 BOX (68999-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05) 2 tray2026-01-14NoNoHistorical