FDA.reportPublic FDA data

MOTPOLY XR

Product NDC
73289-0065
11-digit product format
732890065
Labeler code
73289
Product ID
73289-0065_3a10a8ff-87ff-a36b-e063-6394a90a473c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lacosamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aucta Pharmaceuticals, Inc.
Application
NDA216185
Marketing category
NDA
Marketing start
2023-05-05
Substance
LACOSAMIDE
Active strength
200 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
MOTPOLY XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui2637018, 2637025, 2637027, 2637030, 2637032, 2637035

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
73289-0065-2MOTPOLY XR60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73289-0065MOTPOLY XR (LACOSAMIDE) CAPSULE, EXTENDED RELEASE [AUCTA PHARMACEUTICALS, INC.]4Current NDC, 1 package rows20241103_fb8235b4-4cd3-6f22-e053-6294a90a545c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637018lacosamide 100 MG 24HR Extended Release Oral CapsulePSNfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637027lacosamide 150 MG 24HR Extended Release Oral CapsulePSNfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637032lacosamide 200 MG 24HR Extended Release Oral CapsulePSNfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637025Motpoly XR 100 MG 24HR Extended Release Oral CapsulePSNfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637030Motpoly XR 150 MG 24HR Extended Release Oral CapsulePSNfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637035Motpoly XR 200 MG 24HR Extended Release Oral CapsulePSNfb8235b4-4cd3-6f22-e053-6294a90a545c5
263702524 HR lacosamide 100 MG Extended Release Oral Capsule [Motpoly]SBDfb8235b4-4cd3-6f22-e053-6294a90a545c5
263703024 HR lacosamide 150 MG Extended Release Oral Capsule [Motpoly]SBDfb8235b4-4cd3-6f22-e053-6294a90a545c5
263703524 HR lacosamide 200 MG Extended Release Oral Capsule [Motpoly]SBDfb8235b4-4cd3-6f22-e053-6294a90a545c5
263701824 HR lacosamide 100 MG Extended Release Oral CapsuleSCDfb8235b4-4cd3-6f22-e053-6294a90a545c5
263702724 HR lacosamide 150 MG Extended Release Oral CapsuleSCDfb8235b4-4cd3-6f22-e053-6294a90a545c5
263703224 HR lacosamide 200 MG Extended Release Oral CapsuleSCDfb8235b4-4cd3-6f22-e053-6294a90a545c5
263702524 HR Motpoly 100 MG Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
263703024 HR Motpoly 150 MG Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
263703524 HR Motpoly 200 MG Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637018lacosamide 100 MG 24HR Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637027lacosamide 150 MG 24HR Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637032lacosamide 200 MG 24HR Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637025Motpoly XR 100 MG 24HR Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637030Motpoly XR 150 MG 24HR Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5
2637035Motpoly XR 200 MG 24HR Extended Release Oral CapsuleSYfb8235b4-4cd3-6f22-e053-6294a90a545c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73289-0065-27328900650260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0065-2) 2023-05-05NoNoHistorical