Prescription drug · NDA
Xcopri (Cenobamate) NDC 71699-050
Cenobamate 50 mg/1 · Tablet, Film coated · Oral · SK Life Science, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71699-050-30 | 71699005030 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-30)Marketed from Apr 30, 2021 | |
| 71699-050-99 | 71699005099 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-99)Marketed from Apr 30, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xcopri
- Generic name (nonproprietary)
- cenobamate
- Active ingredients
- Cenobamate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- SK Life Science, Inc.NDC labeler code 71699
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212839
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)GABA A Receptor Positive Modulators (Mechanism)Sodium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 71699-050_a4bdf970-9ffa-11f1-b55a-0800200c9a66SPL ID a4bdf970-9ffa-11f1-b55a-0800200c9a66SPL set ID 565c2126-57ae-4e29-b443-723bbe7e2072RxCUI 2265695, 2265701, 2283503, 2283505, 2283507, 2283509, 2283511, 2283513, 2283517, 2283518, 2283520, 2283522, 2283523, 2283525, 2283527, 2283535, 2283536, 2283538, 2283539, 2283540, 2540431, 2540432, 2683673, 2683674UNII P85X70RZWSUPC 0371699025309, 0371699050998, 0371699150308, 0371699200300, 0371699100303, 0371699204148, 0371699050301
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471699005030followed by a unit qualifier and the quantityPackage 71699-0050-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71699-050
- What is NDC 71699-050?
- 71699-050 is the product NDC for Xcopri (cenobamate), Cenobamate 50 mg/1 tablet, film coated, listed with the FDA by SK Life Science, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xcopri (Cenobamate).
- What is the active ingredient?
- Cenobamate.
- Who is the labeler?
- SK Life Science, Inc., NDC labeler code 71699. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xcopri?
- 5 other product NDCs are listed under this name. See all Xcopri NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xcopri products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xcopricenobamate | Cenobamate 12.5 mg/1 | TabletOral | SK Life Science, Inc. | 71699-204 | 71699-0204-14 |
| Xcopricenobamate | Cenobamate 25 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-025 | 71699-0025-30 |
| Xcopricenobamate | Cenobamate 100 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-100 | 71699-0100-30 |
| Xcopricenobamate | Cenobamate 150 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-150 | 71699-0150-30 |
| Xcopricenobamate | Cenobamate 200 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-200 | 71699-0200-30 |
Other NDCs under NDA 212839
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xcopricenobamate | Cenobamate 25 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-025 |
| Xcopri Maintenance Packcenobamate | — | KitOral | SK Life Science, Inc. | 71699-104 |
| Xcopricenobamate | Cenobamate 100 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-100 |
| Xcopri Maintenance Packcenobamate | — | KitOral | SK Life Science, Inc. | 71699-103 |
| Xcopri Titration Packcenobamate | — | KitOral | SK Life Science, Inc. | 71699-201 |
| Xcopricenobamate | Cenobamate 150 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-150 |
| Xcopricenobamate | Cenobamate 200 mg/1 | Tablet, Film coatedOral | SK Life Science, Inc. | 71699-200 |
| Xcopri Titration Packcenobamate | — | KitOral | SK Life Science, Inc. | 71699-202 |
| Xcopri Titration Packcenobamate | — | KitOral | SK Life Science, Inc. | 71699-203 |
| Xcopricenobamate | Cenobamate 12.5 mg/1 | TabletOral | SK Life Science, Inc. | 71699-204 |