FDA.reportPublic FDA data

LACOSAMIDE

Product NDC
72603-263
11-digit product format
726030263
Labeler code
72603
Product ID
72603-263_1eee4107-cf4c-987c-e063-6394a90a5d3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NorthStar RxLLC
Application
ANDA216335
Marketing category
ANDA
Marketing start
2024-07-15
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
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
72603-263-01LACOSAMIDE20 mL in 1 VIAL, GLASSINJECTION202
72603-263-02LACOSAMIDE10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-263-01ML - Milliliter72603-2634abe6c2f-6cad-420c-8297-3a0472e1fbff12024-10-04
72603-263-02ML - Milliliter72603-263d6120c07-04cb-4ea2-a6b8-65f26d125b3d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-263LACOSAMIDE (LACOSAMIDE) INJECTION [NORTHSTAR RXLLC]2Current NDC, 2 package rows20240806_e969b294-48d9-42a2-a093-0ac715142460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNe969b294-48d9-42a2-a093-0ac7151424602
80997420 ML lacosamide 10 MG/ML InjectionSCDe969b294-48d9-42a2-a093-0ac7151424602
809974lacosamide 200 MG per 20 ML InjectionSYe969b294-48d9-42a2-a093-0ac7151424602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-263-017260302630120 mL in 1 VIAL, GLASS20 mlHistorical
72603-263-027260302630210 VIAL, GLASS in 1 CARTON (72603-263-02) / 20 mL in 1 VIAL, GLASS (72603-263-01) 2024-07-15NoNoCurrent