Lacosamide

Product NDC
62332-171
11-digit product format
623320171
Labeler code
62332
Product ID
62332-171_50c42e50-ab11-460a-a8f6-0edcd1b91613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA204974
Marketing category
ANDA
Marketing start
2022-03-18
Substance
LACOSAMIDE
Active strength
50 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
LACOSAMIDE50 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-171-10Lacosamide100 in 1 CARTONTABLET, FILM COATED10014
62332-171-10Lacosamide10 in 1 BLISTER PACKTABLET, FILM COATED1014
62332-171-30Lacosamide30 in 1 BOTTLETABLET, FILM COATED3014
62332-171-60Lacosamide60 in 1 BOTTLETABLET, FILM COATED6014
62332-171-91Lacosamide1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-171-60EA - Each62332-1713329697c-5274-45e0-bab0-853c5f9eebca12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-171LACOSAMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 5 package rows20231202_07b7b3f2-16a0-4deb-883b-10522676d966.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN07b7b3f2-16a0-4deb-883b-10522676d96614
809992lacosamide 150 MG Oral TabletPSN07b7b3f2-16a0-4deb-883b-10522676d96614
809996lacosamide 200 MG Oral TabletPSN07b7b3f2-16a0-4deb-883b-10522676d96614
810000lacosamide 50 MG Oral TabletPSN07b7b3f2-16a0-4deb-883b-10522676d96614
809987lacosamide 100 MG Oral TabletSCD07b7b3f2-16a0-4deb-883b-10522676d96614
809992lacosamide 150 MG Oral TabletSCD07b7b3f2-16a0-4deb-883b-10522676d96614
809996lacosamide 200 MG Oral TabletSCD07b7b3f2-16a0-4deb-883b-10522676d96614
810000lacosamide 50 MG Oral TabletSCD07b7b3f2-16a0-4deb-883b-10522676d96614
810000lacosamide 50 MG Oral TabletPSNe3658b3c-f193-41a2-acc7-0bb912e271731
810000lacosamide 50 MG Oral TabletSCDe3658b3c-f193-41a2-acc7-0bb912e271731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-171-1062332017110100 BLISTER PACK in 1 CARTON (62332-171-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2022-03-180000-00-00NoNoCurrent
62332-171-306233201713030 TABLET, FILM COATED in 1 BOTTLE (62332-171-30) 2022-03-180000-00-00NoNoCurrent
62332-171-606233201716060 TABLET, FILM COATED in 1 BOTTLE (62332-171-60) 2022-03-180000-00-00NoNoCurrent
62332-171-91623320171911000 TABLET, FILM COATED in 1 BOTTLE (62332-171-91) 2022-03-180000-00-00NoNoCurrent