FDA.reportPublic FDA data

Lacosamide

Product NDC
60687-676
11-digit product format
606870676
Labeler code
60687
Product ID
60687-676_4c5d9cc4-2e98-ae84-e063-6394a90af1d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA214695
Marketing category
ANDA
Marketing start
2022-06-01
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
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
LACOSAMIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809987, 809996, 810000

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-676-11Lacosamide1 in 1 BLISTER PACKTABLET, FILM COATED14
60687-676-57Lacosamide60 in 1 CARTONTABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-676-11EA - Each60687-676fe29aa3c-b829-4f11-aaac-1f1d2175069e12022-05-04
60687-676-57EA - Each60687-676b670d375-ade1-4740-adb3-f8fa8becfc1312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-676LACOSAMIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20241101_19060029-c158-4a37-9261-cfe3b2b5b1e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN19060029-c158-4a37-9261-cfe3b2b5b1e34
809996lacosamide 200 MG Oral TabletPSN19060029-c158-4a37-9261-cfe3b2b5b1e34
810000lacosamide 50 MG Oral TabletPSN19060029-c158-4a37-9261-cfe3b2b5b1e34
809987lacosamide 100 MG Oral TabletSCD19060029-c158-4a37-9261-cfe3b2b5b1e34
809996lacosamide 200 MG Oral TabletSCD19060029-c158-4a37-9261-cfe3b2b5b1e34
810000lacosamide 50 MG Oral TabletSCD19060029-c158-4a37-9261-cfe3b2b5b1e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-676-11606870676111 in 1 BLISTER PACKHistorical
60687-676-576068706765760 BLISTER PACK in 1 CARTON (60687-676-57) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-676-11) 60 blister pack2022-06-010000-00-00NoNoCurrent