Prescription drug · NDA
Trileptal (Oxcarbazepine) NDC 0078-0357
Oxcarbazepine 60 mg/mL · Suspension · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0357-52 | 0007803575200078035752 | 250 mL in 1 BOTTLE (0078-0357-52)Marketed from May 30, 2001 |
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)
- Trileptal
- Generic name (nonproprietary)
- oxcarbazepine
- Active ingredients
- Oxcarbazepine — 60 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021285
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0078-0357_dcd739ce-e938-40e6-8912-ca4f34b49cf3SPL ID dcd739ce-e938-40e6-8912-ca4f34b49cf3SPL set ID 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691bRxCUI 261356, 261360, 262090, 283536, 312136, 312137, 312138, 351992UNII VZI5B1W380
- Pharmacologic class
- Anti-epileptic Agent
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
N400078035752followed by a unit qualifier and the quantityPackage 00078-0357-52. 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)
TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0078-0357
- What is NDC 0078-0357?
- 0078-0357 is the product NDC for Trileptal (oxcarbazepine), Oxcarbazepine 60 mg/mL suspension, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trileptal (Oxcarbazepine).
- What is the active ingredient?
- Oxcarbazepine.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trileptal?
- 3 other product NDCs are listed under this name. See all Trileptal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trileptal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trileptaloxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0337 | 00078-0337-0500078-0337-06 |
| Trileptaloxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0456 | 00078-0456-0500078-0456-35 |
| Trileptaloxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0457 | 00078-0457-0500078-0457-35 |