LACOSAMIDE

Product NDC
25021-791
11-digit product format
250210791
Labeler code
25021
Product ID
25021-791_3cabc3ea-4c98-462e-ae04-ccc0ab25c7a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214301
Marketing category
ANDA
Marketing start
2022-03-17
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
25021-791-20LACOSAMIDE10 in 1 CARTONINJECTION, SOLUTION107
25021-791-20LACOSAMIDE20 mL in 1 VIAL, GLASSINJECTION, SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-791-20ML - Milliliter25021-791021b35e5-e0dc-45cc-9433-f1b474201d2712022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-791LACOSAMIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20240711_6b4536d0-5703-42b0-9f59-46a3e1b75b22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSN6b4536d0-5703-42b0-9f59-46a3e1b75b227
80997420 ML lacosamide 10 MG/ML InjectionSCD6b4536d0-5703-42b0-9f59-46a3e1b75b227
809974lacosamide 200 MG per 20 ML InjectionSY6b4536d0-5703-42b0-9f59-46a3e1b75b227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
25021-791-202502107912010 VIAL, GLASS in 1 CARTON (25021-791-20) / 20 mL in 1 VIAL, GLASS2022-03-170000-00-00NoNoCurrent