Lacosamide

Product NDC
0121-1984
11-digit product format
001211984
Labeler code
0121
Product ID
0121-1984_a95d174d-efee-4ba5-8734-9adaad16be27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI
Application
ANDA209301
Marketing category
ANDA
Marketing start
2022-05-31
Marketing end
0000-00-00
Substance
LACOSAMIDE
Active strength
100 mg/10mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
0121-1984-10Lacosamide10 mL in 1 CUP, UNIT-DOSESOLUTION1022
0121-1984-95Lacosamide10 in 1 TRAYSOLUTION1022
0121-1984-95Lacosamide1 in 1 TRAYSOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1984-10ML - Milliliter0121-1984caa6be51-4c29-4228-bb09-e0a0a0f0752e12022-12-07
0121-1984-95ML - Milliliter0121-1984594e4cc4-0973-4688-9da7-d241ca8328e812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1984LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]22Legacy 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 startMarketing endSampleExclude flagStatus
0121-1984-100012119841010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0121-1984-95001211984951 TRAY in 1 TRAY (0121-1984-95) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1984-10) 1 tray2022-11-010000-00-00NoNoCurrent