FDA.reportPublic FDA data

Lacosamide

Product NDC
43598-087
11-digit product format
435980087
Labeler code
43598
Product ID
43598-087_589d9c35-2a7d-3311-04cb-76c42b369647
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA217718
Marketing category
ANDA
Marketing start
2024-04-22
Substance
LACOSAMIDE
Active strength
10 mg/mL
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
LACOSAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809974

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
43598-087-11Lacosamide20 mL in 1 VIAL, SINGLE-DOSEINJECTION208
43598-087-58Lacosamide10 in 1 CARTONINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-087-11ML - Milliliter43598-087b93ada4a-ca9c-4891-a93a-643f12f8e5f112024-05-16
43598-087-58ML - Milliliter43598-0872e03c6f0-05b4-4657-aab5-f8a842fe934e12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-087LACOSAMIDE INJECTION [DR. REDDY'S LABORATORIES INC.]7Current NDC, 2 package rows20240423_cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809974lacosamide 200 MG in 20 ML InjectionPSNcd5ac33e-6ac5-772b-2ead-d66cbd5bd1b48
80997420 ML lacosamide 10 MG/ML InjectionSCDcd5ac33e-6ac5-772b-2ead-d66cbd5bd1b48
809974lacosamide 200 MG per 20 ML InjectionSYcd5ac33e-6ac5-772b-2ead-d66cbd5bd1b48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-087-114359800871120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
43598-087-584359800875810 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58) / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) 2024-04-22NoNoCurrent