FDA.reportPublic FDA data

Lacosamide

Product NDC
72205-034
11-digit product format
722050034
Labeler code
72205
Product ID
72205-034_4e47a51d-1af3-4e8d-b45b-0c1c3ca0f4d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215379
Marketing category
ANDA
Marketing start
2023-12-22
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
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
LACOSAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui993856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-034-44Lacosamide5 mL in 1 CUP, UNIT-DOSESOLUTION52
72205-034-45Lacosamide10 mL in 1 CUP, UNIT-DOSESOLUTION102
72205-034-46Lacosamide15 mL in 1 CUP, UNIT-DOSESOLUTION152
72205-034-47Lacosamide20 mL in 1 CUP, UNIT-DOSESOLUTION202
72205-034-50Lacosamide1 in 1 BOXSOLUTION12
72205-034-50Lacosamide10 in 1 TRAYSOLUTION102
72205-034-74Lacosamide200 mL in 1 BOTTLE, PLASTICSOLUTION2002
72205-034-75Lacosamide465 mL in 1 BOTTLE, PLASTICSOLUTION4652
72205-034-91Lacosamide1 in 1 BOXSOLUTION12
72205-034-91Lacosamide10 in 1 TRAYSOLUTION102
72205-034-93Lacosamide1 in 1 BOXSOLUTION12
72205-034-93Lacosamide10 in 1 TRAYSOLUTION102
72205-034-94Lacosamide10 in 1 TRAYSOLUTION102
72205-034-94Lacosamide1 in 1 BOXSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-034-74ML - Milliliter72205-0346494c70d-1486-4450-81e9-54481a0c8e9e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-034LACOSAMIDE SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 14 package rows20231230_b9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN024bca92-cac5-4832-a1ff-c1b3d5994ba0100
993856lacosamide 10 MG/ML Oral SolutionSCD024bca92-cac5-4832-a1ff-c1b3d5994ba0100
993856lacosamide 10 MG per 1 ML Oral SolutionSY024bca92-cac5-4832-a1ff-c1b3d5994ba0100
993856lacosamide 10 MG in 1 mL Oral SolutionPSNb9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b2
993856lacosamide 10 MG/ML Oral SolutionSCDb9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b2
993856lacosamide 10 MG per 1 ML Oral SolutionSYb9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-034-44722050034445 mL in 1 CUP, UNIT-DOSE5 mlHistorical
72205-034-457220500344510 mL in 1 CUP, UNIT-DOSE10 mlHistorical
72205-034-467220500344615 mL in 1 CUP, UNIT-DOSE15 mlHistorical
72205-034-477220500344720 mL in 1 CUP, UNIT-DOSE20 mlHistorical
72205-034-50722050034501 TRAY in 1 BOX (72205-034-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (72205-034-44) 1 tray2024-12-12NoNoCurrent
72205-034-7472205003474200 mL in 1 BOTTLE, PLASTIC (72205-034-74) 200 ml2023-12-29NoNoCurrent
72205-034-7572205003475465 mL in 1 BOTTLE, PLASTIC (72205-034-75) 465 ml2023-12-29NoNoCurrent
72205-034-91722050034911 TRAY in 1 BOX (72205-034-91) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (72205-034-45) 1 tray2024-12-12NoNoCurrent
72205-034-93722050034931 TRAY in 1 BOX (72205-034-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (72205-034-46) 1 tray2024-12-12NoNoCurrent
72205-034-94722050034941 TRAY in 1 BOX (72205-034-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (72205-034-47) 1 tray2024-12-12NoNoCurrent