Prescription drug · ANDA
Rufinamide NDC 31722-688
Rufinamide 40 mg/mL · Suspension · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-688-46 | 31722068846 | 1 BOTTLE in 1 CARTON (31722-688-46) / 460 mL in 1 BOTTLEMarketed from Dec 5, 2023 |
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)
- Rufinamide
- Generic name (nonproprietary)
- rufinamide
- Active ingredients
- Rufinamide — 40 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216841
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-688_0d914e03-3610-c662-e063-6294a90a5430SPL ID 0d914e03-3610-c662-e063-6294a90a5430SPL set ID 1c2f9bf2-1711-4975-af02-32614db25addRxCUI 1092357UNII WFW942PR79
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
N431722068846followed by a unit qualifier and the quantityPackage 31722-0688-46. 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)
Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide oral suspension 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.
Other NDCs under ANDA 216841
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 |
|---|---|---|---|---|
| Rufinamide | Rufinamide 40 mg/mL | SuspensionOral | NorthStar RxLLC | 72603-261 |