Lacosamide

Product NDC
0121-0992
11-digit product format
001210992
Labeler code
0121
Product ID
0121-0992_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
50 mg/5mL
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
0121-0992-05Lacosamide5 mL in 1 CUP, UNIT-DOSESOLUTION522
0121-0992-95Lacosamide10 in 1 TRAYSOLUTION1022
0121-0992-95Lacosamide1 in 1 CASESOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0992-05ML - Milliliter0121-0992a8d61cc8-f993-4bf8-a76d-b00f716755b712022-12-07
0121-0992-95ML - Milliliter0121-0992020b2aec-7fcf-43fc-acc3-9e61a03c4ac912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0992LACOSAMIDE 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
0121-0992-05001210992055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0992-95001210992951 TRAY in 1 CASE (0121-0992-95) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0992-05) 1 tray2022-11-010000-00-00NoNoCurrent