FDA.reportPublic FDA data

Xcopri

Product NDC
71699-025
11-digit product format
716990025
Labeler code
71699
Product ID
71699-025_8e4ae306-0c50-4fe9-92fd-f79be8299f4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cenobamate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SK Life Science, Inc.
Application
NDA212839
Marketing category
NDA
Marketing start
2024-04-06
Substance
CENOBAMATE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], GABA A Receptor Positive Modulators [MoA], Sodium Channel Antagonists [MoA]
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
Xcopri
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CENOBAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP85X70RZWS
Rxcui2265695, 2265701, 2283503, 2283505, 2283507, 2283509, 2283511, 2283513, 2283517, 2283518, 2283520, 2283522, 2283523, 2283525, 2283527, 2283535, 2283536, 2283538, 2283539, 2283540

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bfc06707-697c-4c73-94f1-ce1fe39a2a97Product name120200506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71699-025-30Xcopri30 in 1 BOTTLETABLET, FILM COATED3043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71699-025-30EA - Each71699-0254f6297e4-3fe5-498a-9312-080351bef4e412024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71699-025XCOPRI TITRATION PACK (CENOBAMATE) KIT XCOPRI (CENOBAMATE) TABLET, FILM COATED XCOPRI MAINTENANCE PACK (CENOBAMATE) KIT XCOPRI (CENOBAMATE) TABLET [SK LIFE SCIENCE, INC.]36Current NDC, 1 package rows20250510_565c2126-57ae-4e29-b443-723bbe7e2072.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2283536{14 (cenobamate 100 MG Oral Tablet [Xcopri]) / 14 (cenobamate 50 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 50 MG (14), 100 MG (14) 28 Count]BPCK565c2126-57ae-4e29-b443-723bbe7e207243
2683674{14 (cenobamate 12.5 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 12.5 MG 14 Count]BPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283538{14 (cenobamate 12.5 MG Oral Tablet [Xcopri]) / 14 (cenobamate 25 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 12.5 MG (14), 25 MG (14) 28 Count]BPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283540{14 (cenobamate 150 MG Oral Tablet [Xcopri]) / 14 (cenobamate 200 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 150 MG (14), 200 MG (14) 28 Count]BPCK565c2126-57ae-4e29-b443-723bbe7e207243
2540432{28 (cenobamate 100 MG Oral Tablet [Xcopri]) / 28 (cenobamate 150 MG Oral Tablet [Xcopri]) } Pack [Xcopri 250 MG Maintenance Pack - 100 MG (28), 150 MG (28) 56 Count]BPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283518{28 (cenobamate 150 MG Oral Tablet [Xcopri]) / 28 (cenobamate 200 MG Oral Tablet) } Pack [Xcopri 350 MG Maintenance Pack]BPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283535{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } PackGPCK565c2126-57ae-4e29-b443-723bbe7e207243
2683673{14 (cenobamate 12.5 MG Oral Tablet) } PackGPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283523{14 (cenobamate 12.5 MG Oral Tablet) / 14 (cenobamate 25 MG Oral Tablet) } PackGPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283539{14 (cenobamate 150 MG Oral Tablet) / 14 (cenobamate 200 MG Oral Tablet) } PackGPCK565c2126-57ae-4e29-b443-723bbe7e207243
2540431{28 (cenobamate 100 MG Oral Tablet) / 28 (cenobamate 150 MG Oral Tablet) } PackGPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283517{28 (cenobamate 150 MG Oral Tablet) / 28 (cenobamate 200 MG Oral Tablet) } PackGPCK565c2126-57ae-4e29-b443-723bbe7e207243
2283503cenobamate 100 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2540431cenobamate 100 MG Oral Tablet (28) / cenobamate 150 MG Oral Tablet (28) Maintenance PackPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283520cenobamate 12.5 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283523cenobamate 12.5 MG Oral Tablet (14) / cenobamate 25 MG Oral Tablet (14) Titration PackPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283507cenobamate 150 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283539cenobamate 150 MG Oral Tablet (14) / cenobamate 200 MG Oral Tablet (14) Titration PackPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283517cenobamate 150 MG Oral Tablet (28) / cenobamate 200 MG Oral Tablet (28) Maintenance PackPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283511cenobamate 200 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283522cenobamate 25 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2265695cenobamate 50 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283535cenobamate 50 MG Oral Tablet (14) / cenobamate 100 MG Oral Tablet (14) Titration PackPSN565c2126-57ae-4e29-b443-723bbe7e207243
2683673cenobamate Titration Pack - 12.5 MG 14 CountPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283505XCOPRI 100 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283525XCOPRI 12.5 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283509XCOPRI 150 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283513XCOPRI 200 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283527XCOPRI 25 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2540432XCOPRI 250 MG Maintenance Pack - 100 MG (28), 150 MG (28) 56 CountPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283518XCOPRI 350 MG Maintenance PackPSN565c2126-57ae-4e29-b443-723bbe7e207243
2265701XCOPRI 50 MG Oral TabletPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283538XCOPRI Titration Pack - 12.5 MG (14), 25 MG (14) 28 CountPSN565c2126-57ae-4e29-b443-723bbe7e207243
2683674XCOPRI Titration Pack - 12.5 MG 14 CountPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283540XCOPRI Titration Pack - 150 MG (14), 200 MG (14) 28 CountPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283536XCOPRI Titration Pack - 50 MG (14), 100 MG (14) 28 CountPSN565c2126-57ae-4e29-b443-723bbe7e207243
2283505cenobamate 100 MG Oral Tablet [Xcopri]SBD565c2126-57ae-4e29-b443-723bbe7e207243
2283525cenobamate 12.5 MG Oral Tablet [Xcopri]SBD565c2126-57ae-4e29-b443-723bbe7e207243
2283509cenobamate 150 MG Oral Tablet [Xcopri]SBD565c2126-57ae-4e29-b443-723bbe7e207243
2283513cenobamate 200 MG Oral Tablet [Xcopri]SBD565c2126-57ae-4e29-b443-723bbe7e207243
2283527cenobamate 25 MG Oral Tablet [Xcopri]SBD565c2126-57ae-4e29-b443-723bbe7e207243
2265701cenobamate 50 MG Oral Tablet [Xcopri]SBD565c2126-57ae-4e29-b443-723bbe7e207243
2283503cenobamate 100 MG Oral TabletSCD565c2126-57ae-4e29-b443-723bbe7e207243
2283520cenobamate 12.5 MG Oral TabletSCD565c2126-57ae-4e29-b443-723bbe7e207243
2283507cenobamate 150 MG Oral TabletSCD565c2126-57ae-4e29-b443-723bbe7e207243
2283511cenobamate 200 MG Oral TabletSCD565c2126-57ae-4e29-b443-723bbe7e207243
2283522cenobamate 25 MG Oral TabletSCD565c2126-57ae-4e29-b443-723bbe7e207243
2265695cenobamate 50 MG Oral TabletSCD565c2126-57ae-4e29-b443-723bbe7e207243
2540431cenobamate 100 MG Oral Tablet (28) / cenobamate 150 MG Oral Tablet (28) Maintenance PackSY565c2126-57ae-4e29-b443-723bbe7e207243
2283523cenobamate 12.5 MG Oral Tablet (14) / cenobamate 25 MG Oral Tablet (14) Titration PackSY565c2126-57ae-4e29-b443-723bbe7e207243
2283539cenobamate 150 MG Oral Tablet (14) / cenobamate 200 MG Oral Tablet (14) Titration PackSY565c2126-57ae-4e29-b443-723bbe7e207243
2283517cenobamate 150 MG Oral Tablet (28) / cenobamate 200 MG Oral Tablet (28) Maintenance PackSY565c2126-57ae-4e29-b443-723bbe7e207243
2283535cenobamate 50 MG Oral Tablet (14) / cenobamate 100 MG Oral Tablet (14) Titration PackSY565c2126-57ae-4e29-b443-723bbe7e207243
2683673cenobamate Titration Pack - 12.5 MG 14 CountSY565c2126-57ae-4e29-b443-723bbe7e207243
2283505Xcopri 100 MG Oral TabletSY565c2126-57ae-4e29-b443-723bbe7e207243
2283525Xcopri 12.5 MG Oral TabletSY565c2126-57ae-4e29-b443-723bbe7e207243
2283509Xcopri 150 MG Oral TabletSY565c2126-57ae-4e29-b443-723bbe7e207243
2283513Xcopri 200 MG Oral TabletSY565c2126-57ae-4e29-b443-723bbe7e207243
2283527Xcopri 25 MG Oral TabletSY565c2126-57ae-4e29-b443-723bbe7e207243
2540432Xcopri 250 MG Maintenance Pack - 100 MG (28), 150 MG (28) 56 CountSY565c2126-57ae-4e29-b443-723bbe7e207243
2283518Xcopri 350 MG Maintenance PackSY565c2126-57ae-4e29-b443-723bbe7e207243
2265701Xcopri 50 MG Oral TabletSY565c2126-57ae-4e29-b443-723bbe7e207243
2283538Xcopri Titration Pack - 12.5 MG (14), 25 MG (14) 28 CountSY565c2126-57ae-4e29-b443-723bbe7e207243
2683674Xcopri Titration Pack - 12.5 MG 14 CountSY565c2126-57ae-4e29-b443-723bbe7e207243
2283540Xcopri Titration Pack - 150 MG (14), 200 MG (14) 28 CountSY565c2126-57ae-4e29-b443-723bbe7e207243
2283536Xcopri Titration Pack - 50 MG (14), 100 MG (14) 28 CountSY565c2126-57ae-4e29-b443-723bbe7e207243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71699-025-307169900253030 TABLET, FILM COATED in 1 BOTTLE (71699-025-30) 2024-04-06NoNoCurrent