MOTPOLY XR

Basic Information

Product Name

MOTPOLY XR

FDA Product Code

73289-0064

Regulatory Information

NDC Product Code

73289-0064

Application Number

NDA216185

Marketing Category

C73594

Effective Date

December 21, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use MOTPOLY XR safely and effectively. See full prescribing information for MOTPOLY XR. MOTPOLY XR(lacosamide)™ extended-release capsules, for oral use, CV Initial U.S. Approval: 2008

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ETHYLCELLULOSE (7 MPA.S)

Code: H3UP11403C

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

LACOSAMIDE

Quantity: 150 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

Basic Information

Regulatory Information

Company Information

Active Ingredients

ETHYLCELLULOSE (7 MPA.S)

POVIDONE

TRIACETIN

HYPROMELLOSE 2910 (5 MPA.S)

MICROCRYSTALLINE CELLULOSE

TITANIUM DIOXIDE

TRIETHYL CITRATE

FERRIC OXIDE YELLOW

FERRIC OXIDE RED

Active Moieties

LACOSAMIDE