Prescription drug · ANDA
Rufinamide NDC 59651-563
Rufinamide 40 mg/mL · Suspension · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-563-60 | 5965105636059651056360 | 1 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLEMarketed from Oct 26, 2022 |
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
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216549
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-563_855369b6-9f5b-4951-9115-dbb9a74ac53bSPL ID 855369b6-9f5b-4951-9115-dbb9a74ac53bSPL set ID 444544f0-7622-4eef-b218-f241bd50d4afRxCUI 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
N459651056360followed by a unit qualifier and the quantityPackage 59651-0563-60. 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.
About NDC 59651-563
- What is NDC 59651-563?
- 59651-563 is the product NDC for Rufinamide, Rufinamide 40 mg/mL suspension, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rufinamide.
- What is the active ingredient?
- Rufinamide.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rufinamide?
- 20 other product NDCs are listed under this name. See all Rufinamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rufinamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rufinamide | Rufinamide 40 mg/mL | SuspensionOral | American Health Packaging | 60687-824 | 60687-0824-08 |
| Rufinamide | Rufinamide 40 mg/mL | SuspensionOral | Novadoz Pharmaceuticals LLC | 72205-038 | 72205-0038-77 |
| Rufinamide | Rufinamide 40 mg/mL | SuspensionOral | NorthStar RxLLC | 72603-261 | 72603-0261-01 |
| Rufinamide | Rufinamide 40 mg/mL | SuspensionOral | Camber Pharmaceuticals, Inc. | 31722-688 | 31722-0688-46 |
| Rufinamide | Rufinamide 200 mg/1 | TabletOral | Micro Labs Limited | 42571-391 | 42571-0391-12 |
| Rufinamide | Rufinamide 400 mg/1 | TabletOral | Micro Labs Limited | 42571-392 | 42571-0392-12 |
| Rufinamide | Rufinamide 40 mg/mL | SuspensionOral | Lupin Pharmaceuticals, Inc. | 68180-797 | 68180-0797-01 |
| Rufinamide | Rufinamide 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-616 | 59651-0616-08 |
| Rufinamide | Rufinamide 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-617 | 59651-0617-08 |
| Rufinamide | Rufinamide 200 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-803 | 68180-0803-16 |