Lacosamide

Product NDC
69367-351
11-digit product format
693670351
Labeler code
69367
Product ID
69367-351_600757f7-b2e8-4c8e-aaf6-c468d7ada9a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA205237
Marketing category
ANDA
Marketing start
2023-07-10
Substance
LACOSAMIDE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lacosamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809987, 809992, 809996, 810000

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
69367-351-60Lacosamide60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-351-60EA - Each69367-3519e63eeef-9968-46bb-94e9-9ba7b135310912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-351LACOSAMIDE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230718_ecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSNecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
809992lacosamide 150 MG Oral TabletPSNecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
809996lacosamide 200 MG Oral TabletPSNecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
810000lacosamide 50 MG Oral TabletPSNecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
809987lacosamide 100 MG Oral TabletSCDecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
809992lacosamide 150 MG Oral TabletSCDecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
809996lacosamide 200 MG Oral TabletSCDecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
810000lacosamide 50 MG Oral TabletSCDecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb863
809987lacosamide 100 MG Oral TabletPSN47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
809992lacosamide 150 MG Oral TabletPSN47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
809996lacosamide 200 MG Oral TabletPSN47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
810000lacosamide 50 MG Oral TabletPSN47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
809987lacosamide 100 MG Oral TabletSCD47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
809992lacosamide 150 MG Oral TabletSCD47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
809996lacosamide 200 MG Oral TabletSCD47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1
810000lacosamide 50 MG Oral TabletSCD47ae2f1f-d135-4f4e-acc2-500c1afa7b8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-351-606936703516060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-351-60) 2023-07-10NoNoHistorical