MOTPOLY XR

Product NDC
73289-0064
11-digit product format
732890064
Labeler code
73289
Product ID
73289-0064_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
150 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216185-001MOTPOLY XRLACOSAMIDE100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04
N216185-002MOTPOLY XRLACOSAMIDE150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04
N216185-003MOTPOLY XRLACOSAMIDE200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216185-001113379432040-06-05U-3660Drug product2023-08-01
N216185-001113379432040-06-05U-3954Drug product2023-08-01
N216185-001118833742040-06-05U-3660Drug product2024-08-21
N216185-001118833742040-06-05U-3954Drug product2024-08-21
N216185-001120424742040-06-05U-3660Drug product2024-08-21
N216185-001120424742040-06-05U-3954Drug product2024-08-21
N216185-002113379432040-06-05U-3660Drug product2023-08-01
N216185-002113379432040-06-05U-3954Drug product2023-08-01
N216185-002118833742040-06-05U-3660Drug product2024-08-21
N216185-002118833742040-06-05U-3954Drug product2024-08-21
N216185-002120424742040-06-05U-3660Drug product2024-08-21
N216185-002120424742040-06-05U-3954Drug product2024-08-21
N216185-003113379432040-06-05U-3660Drug product2023-08-01
N216185-003113379432040-06-05U-3954Drug product2023-08-01
N216185-003118833742040-06-05U-3660Drug product2024-08-21
N216185-003118833742040-06-05U-3954Drug product2024-08-21
N216185-003120424742040-06-05U-3660Drug product2024-08-21
N216185-003120424742040-06-05U-3954Drug product2024-08-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216185-002MOTPOLY XR150MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216185-003MOTPOLY XR200MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2023-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216185-001MOTPOLY XR100MGCAPSULE, EXTENDED RELEASE / ORALRLD2023-05-048072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 6 · 231 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216185-001113379432040-06-05U-3660Drug product2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-001113379432040-06-05U-3954Drug product2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-001118833742040-06-05U-3660Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-001118833742040-06-05U-3954Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-001120424742040-06-05U-3660Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-001120424742040-06-05U-3954Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002113379432040-06-05U-3660Drug product2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002113379432040-06-05U-3954Drug product2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002118833742040-06-05U-3954Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002118833742040-06-05U-3660Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002120424742040-06-05U-3954Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-002120424742040-06-05U-3660Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003113379432040-06-05U-3660Drug product2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003113379432040-06-05U-3954Drug product2023-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003118833742040-06-05U-3954Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003118833742040-06-05U-3660Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003120424742040-06-05U-3954Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216185-003120424742040-06-05U-3660Drug product2024-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001113379432040-06-05U-3660Drug product2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001113379432040-06-05U-3954Drug product2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001118833742040-06-05U-3660Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001118833742040-06-05U-3954Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001120424742040-06-05U-3660Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-001120424742040-06-05U-3954Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002113379432040-06-05U-3660Drug product2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002113379432040-06-05U-3954Drug product2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002118833742040-06-05U-3954Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002118833742040-06-05U-3660Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002120424742040-06-05U-3954Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-002120424742040-06-05U-3660Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003113379432040-06-05U-3660Drug product2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003113379432040-06-05U-3954Drug product2023-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003118833742040-06-05U-3954Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003118833742040-06-05U-3660Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003120424742040-06-05U-3954Drug product2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216185-003120424742040-06-05U-3660Drug product2024-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N216185-001113379432040-06-05U-3660Drug product2023-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216185-001113379432040-06-05U-3954Drug product2023-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216185-001118833742040-06-05U-3660Drug product2024-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216185-001118833742040-06-05U-3954Drug product2024-08-216a471c1ec25d…

Additional Listing Data#

Finished product
Yes
Brand name base
MOTPOLY XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
563KS2PQY5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637018Internal RxNorm lookup
2637025Internal RxNorm lookup
2637027Internal RxNorm lookup
2637030Internal RxNorm lookup
2637032Internal RxNorm lookup
2637035Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb8235b4-4cd3-6f22-e053-6294a90a545cAvailable on FDA.report

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
73289-0064-2MOTPOLY XR60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73289-0064MOTPOLY XR (LACOSAMIDE) CAPSULE, EXTENDED RELEASE [AUCTA PHARMACEUTICALS, INC.]4Current NDC, 1 package rows20241103_fb8235b4-4cd3-6f22-e053-6294a90a545c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOTPOLY XRLACOSAMIDEAucta Pharmaceuticals, Inc.fb8235b4-4cd3-6f22-e053-6294a90a545c2025-07-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 216185
application number: NDA216185
ndc (product): 73289-0064

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
73289-0064-27328900640260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0064-2) 2023-05-05NoNoCurrent