FDA.reportPublic FDA data

LACOSAMIDE

Product NDC
70069-471
11-digit product format
700690471
Labeler code
70069
Product ID
70069-471_7d259027-e0df-41af-8ead-40aebffd8b59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA214960
Marketing category
ANDA
Marketing start
2024-10-10
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-471-01LACOSAMIDE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2013
70069-471-10LACOSAMIDE10 in 1 CARTONINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-471-01ML - Milliliter70069-47119fd2670-d2fa-4b43-a66d-fe617cd92a2a12024-11-05
70069-471-10ML - Milliliter70069-4718049f7bf-de12-45cf-bc01-cac4ebc6ffc812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-471LACOSAMIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]13Current NDC, 2 package rows20241018_00203a7b-e774-45f7-ac6b-48db6d32a48a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSN00203a7b-e774-45f7-ac6b-48db6d32a48a13
80997420 ML lacosamide 10 MG/ML InjectionSCD00203a7b-e774-45f7-ac6b-48db6d32a48a13
809974lacosamide 200 MG per 20 ML InjectionSY00203a7b-e774-45f7-ac6b-48db6d32a48a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-471-017006904710120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
70069-471-107006904711010 VIAL, SINGLE-DOSE in 1 CARTON (70069-471-10) / 20 mL in 1 VIAL, SINGLE-DOSE (70069-471-01) 2024-10-10NoNoCurrent