FDA.reportPublic FDA data

LACOSAMIDE

Product NDC
72865-235
11-digit product format
728650235
Labeler code
72865
Product ID
72865-235_f3394cab-e834-326c-e053-2a95a90af10e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA216335
Marketing category
ANDA
Marketing start
2023-01-25
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
Rxcui809974

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
72865-235-01LACOSAMIDE20 mL in 1 VIAL, GLASSINJECTION201
72865-235-10LACOSAMIDE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-235-01ML - Milliliter72865-235b9056686-648d-4f04-bc30-806d09c8df8b12024-10-04
72865-235-10ML - Milliliter72865-2359d5c1b03-aca1-4140-b2c8-5ff3cd91bd2712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-235LACOSAMIDE (LACOSAMIDE) INJECTION [XLCARE PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230129_c7793da3-787b-4364-9192-7caab49066f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNc7793da3-787b-4364-9192-7caab49066f11
80997420 ML lacosamide 10 MG/ML InjectionSCDc7793da3-787b-4364-9192-7caab49066f11
809974lacosamide 200 MG per 20 ML InjectionSYc7793da3-787b-4364-9192-7caab49066f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-235-017286502350120 mL in 1 VIAL, GLASS20 mlHistorical
72865-235-107286502351010 VIAL, GLASS in 1 CARTON (72865-235-10) / 20 mL in 1 VIAL, GLASS (72865-235-01) 2023-01-25NoNoCurrent