FDA.reportPublic FDA data

LACOSAMIDE

Product NDC
31722-812
11-digit product format
317220812
Labeler code
31722
Product ID
31722-812_4ce360cc-8d3c-b68d-e063-6294a90a91ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204787
Marketing category
ANDA
Marketing start
2022-03-17
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, 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
31722-812-05LACOSAMIDE500 in 1 BOTTLETABLET, FILM COATED5006
31722-812-18LACOSAMIDE180 in 1 BOTTLETABLET, FILM COATED1806
31722-812-32LACOSAMIDE100 in 1 BLISTER PACKTABLET, FILM COATED1006
31722-812-60LACOSAMIDE60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-812-60EA - Each31722-8122215dc96-67a1-4af4-9081-24c1a91b141b12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-812LACOSAMIDE (LACOSAMIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20240430_c5b91128-f838-4e98-9684-5f477fc7af06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSNc5b91128-f838-4e98-9684-5f477fc7af066
809992lacosamide 150 MG Oral TabletPSNc5b91128-f838-4e98-9684-5f477fc7af066
809996lacosamide 200 MG Oral TabletPSNc5b91128-f838-4e98-9684-5f477fc7af066
810000lacosamide 50 MG Oral TabletPSNc5b91128-f838-4e98-9684-5f477fc7af066
809987lacosamide 100 MG Oral TabletSCDc5b91128-f838-4e98-9684-5f477fc7af066
809992lacosamide 150 MG Oral TabletSCDc5b91128-f838-4e98-9684-5f477fc7af066
809996lacosamide 200 MG Oral TabletSCDc5b91128-f838-4e98-9684-5f477fc7af066
810000lacosamide 50 MG Oral TabletSCDc5b91128-f838-4e98-9684-5f477fc7af066
809987lacosamide 100 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
809992lacosamide 150 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
809996lacosamide 200 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
810000lacosamide 50 MG Oral TabletPSN264c3718-67ea-4483-b036-2514c853635a1
809987lacosamide 100 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1
809992lacosamide 150 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1
809996lacosamide 200 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1
810000lacosamide 50 MG Oral TabletSCD264c3718-67ea-4483-b036-2514c853635a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-812-0531722081205500 TABLET, FILM COATED in 1 BOTTLE (31722-812-05) 2022-03-170000-00-00NoNoCurrent
31722-812-1831722081218180 TABLET, FILM COATED in 1 BOTTLE (31722-812-18) 2022-03-170000-00-00NoNoCurrent
31722-812-3231722081232100 TABLET, FILM COATED in 1 BLISTER PACK (31722-812-32) 2022-03-170000-00-00NoNoCurrent
31722-812-603172208126060 TABLET, FILM COATED in 1 BOTTLE (31722-812-60) 2022-03-170000-00-00NoNoCurrent