Lacosamide

Product NDC
14445-132
11-digit product format
144450132
Labeler code
14445
Product ID
14445-132_c16a4d24-f5e3-40a3-b8d7-072494029396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA208308
Marketing category
ANDA
Marketing start
2022-03-20
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
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-132-60Lacosamide60 in 1 BOTTLETABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-132LACOSAMIDE TABLET [INDOCO REMEDIES LIMITED ]7Current NDC, Legacy NDC, 1 package rows20220320_145b4fae-ce6d-43e8-a474-fcb9dff92a53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN145b4fae-ce6d-43e8-a474-fcb9dff92a537
809992lacosamide 150 MG Oral TabletPSN145b4fae-ce6d-43e8-a474-fcb9dff92a537
809996lacosamide 200 MG Oral TabletPSN145b4fae-ce6d-43e8-a474-fcb9dff92a537
810000lacosamide 50 MG Oral TabletPSN145b4fae-ce6d-43e8-a474-fcb9dff92a537
809987lacosamide 100 MG Oral TabletSCD145b4fae-ce6d-43e8-a474-fcb9dff92a537
809992lacosamide 150 MG Oral TabletSCD145b4fae-ce6d-43e8-a474-fcb9dff92a537
809996lacosamide 200 MG Oral TabletSCD145b4fae-ce6d-43e8-a474-fcb9dff92a537
810000lacosamide 50 MG Oral TabletSCD145b4fae-ce6d-43e8-a474-fcb9dff92a537

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14445-132-601444501326060 TABLET in 1 BOTTLE (14445-132-60) 60 tablet2022-03-200000-00-00NoNoCurrent