Prescription drug · ANDA
Oxcarbazepine NDC 70518-2370
Oxcarbazepine 300 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2370-2 | 70518237002 | 100 POUCH in 1 BOX (70518-2370-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-2370-3)Marketed from Oct 4, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Oxcarbazepine
- Generic name (nonproprietary)
- oxcarbazepine
- Active ingredients
- Oxcarbazepine — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078069
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70518-2370_574798d0-1faf-7f23-e063-6294a90a4ef8SPL ID 574798d0-1faf-7f23-e063-6294a90a4ef8SPL set ID ffc8d10c-0049-4fe5-beb8-79cc6a197edeRxCUI 312137UNII 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
N470518237002followed by a unit qualifier and the quantityPackage 70518-2370-02. 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)
Oxcarbazepine tablets are 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. Oxcarbazepine tablets are 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.
Other NDCs under ANDA 078069
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 |
|---|---|---|---|---|
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4465 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4480 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3816 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-062 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-061 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-063 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2253 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7262 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2254 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2276 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7263 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7264 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4320 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4323 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9186 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-6834 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1597 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0090 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1594 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7593 |
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