Prescription drug · NDA
Banzel (Rufinamide) NDC 62856-583
Rufinamide 400 mg/1 · Tablet, Film coated · Oral · Eisai Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62856-583-14 | 6285605831462856058314 | 14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14)Marketed from Aug 8, 2018 · Sample package | |
| 62856-583-52 | 6285605835262856058352 | 120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52)Marketed from Nov 14, 2008 |
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)
- Banzel
- Generic name (nonproprietary)
- rufinamide
- Active ingredients
- Rufinamide — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Eisai Inc.NDC labeler code 62856
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021911
- Marketing start
- Listing expires
- Identifiers
- Product ID 62856-583_0cc6f13a-0289-45f7-980e-3196d7489d75SPL ID 0cc6f13a-0289-45f7-980e-3196d7489d75SPL set ID 0a3fa925-1abd-458a-bd57-4ae780a1ef2dRxCUI 824295, 824299, 824301, 824303, 1092357, 1092360UNII WFW942PR79UPC 0362856584463, 0362856582520
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
N462856058314followed by a unit qualifier and the quantityPackage 62856-0583-14. 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)
1 I NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62856-583
- What is NDC 62856-583?
- 62856-583 is the product NDC for Banzel (rufinamide), Rufinamide 400 mg/1 tablet, film coated, listed with the FDA by Eisai Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Banzel (Rufinamide).
- What is the active ingredient?
- Rufinamide.
- Who is the labeler?
- Eisai Inc., NDC labeler code 62856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Banzel?
- 2 other product NDCs are listed under this name. See all Banzel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Banzel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Banzelrufinamide | Rufinamide 40 mg/mL | SuspensionOral | Eisai Inc. | 62856-584 | 62856-0584-46 |
| Banzelrufinamide | Rufinamide 200 mg/1 | Tablet, Film coatedOral | Eisai Inc. | 62856-582 | 62856-0582-0462856-0582-52 |
Other NDCs under NDA 021911
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 |
|---|---|---|---|---|
| Banzelrufinamide | Rufinamide 200 mg/1 | Tablet, Film coatedOral | Eisai Inc. | 62856-582 |