FDA.reportPublic FDA data

Lacosamide

Product NDC
0121-3036
11-digit product format
001213036
Labeler code
0121
Product ID
0121-3036_80024eb8-f6ab-420a-94df-dc5dd9ffb9b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA216151
Marketing category
ANDA
Marketing start
2022-08-26
Substance
LACOSAMIDE
Active strength
150 mg/15mL
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
LACOSAMIDE150 mg/15mL

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
0121-3036-15Lacosamide15 mL in 1 CUP, UNIT-DOSESOLUTION1522
0121-3036-95Lacosamide10 in 1 TRAYSOLUTION1022
0121-3036-95Lacosamide1 in 1 CASESOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-3036-15ML - Milliliter0121-303680305577-f76b-4ead-8a10-18c18216670d12023-09-05
0121-3036-95ML - Milliliter0121-30361ba5f15f-2e08-4bf8-a545-4b6400aaa3ee12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-3036LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]22Current NDC, 3 package rows20240601_75de00d8-d2e7-4025-be4e-f49299068e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN75de00d8-d2e7-4025-be4e-f49299068e7e22
993856lacosamide 10 MG/ML Oral SolutionSCD75de00d8-d2e7-4025-be4e-f49299068e7e22
993856lacosamide 10 MG per 1 ML Oral SolutionSY75de00d8-d2e7-4025-be4e-f49299068e7e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-3036-150012130361515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
0121-3036-95001213036951 TRAY in 1 CASE (0121-3036-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-3036-15) 1 tray2023-06-30NoNoHistorical