Prescription drug · ANDA
Rufinamide NDC 0054-0528
Rufinamide 40 mg/mL · Suspension · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0528-63 | 00054052863 | 1 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLEMarketed from Nov 1, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207363
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80SPL ID eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80SPL set ID 8ef75997-06f6-441f-8320-a23bc13ca2d9RxCUI 1092357UNII WFW942PR79UPC 0300540528638
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
N400054052863followed by a unit qualifier and the quantityPackage 00054-0528-63. 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 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 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 207363
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 | American Health Packaging | 60687-824 |