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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| P85X70RZWS | CENOBAMATE | 913088-80-9 | CENOBAMATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71699-025-30 | 71699002530 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-025-30) | 2024-04-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Xcopri Titration Pack | SK Life Science, Inc. | 2025-09-25 | HUMAN PRESCRIPTION DRUG LABEL | 43 |