Prescription drug · ANDA
Rufinamide NDC 68180-797
Rufinamide 40 mg/mL · Suspension · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-797-01 | 6818007970168180079701 | 1 BOTTLE in 1 CARTON (68180-797-01) / 460 mL in 1 BOTTLEMarketed from Jun 22, 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
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213457
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-797_47c9752b-a06d-46af-a029-9213e2474378SPL ID 47c9752b-a06d-46af-a029-9213e2474378SPL set ID 1e671632-d5bd-499a-ba06-0d1dc0d99622RxCUI 1092357UNII WFW942PR79UPC 0368180797012
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
N468180079701followed by a unit qualifier and the quantityPackage 68180-0797-01. 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 68180-797
- What is NDC 68180-797?
- 68180-797 is the product NDC for Rufinamide, Rufinamide 40 mg/mL suspension, listed with the FDA by Lupin Pharmaceuticals, Inc.. 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?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 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 |
| Rufinamide | Rufinamide 400 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-804 | 68180-0804-16 |