Prescription drug · ANDA
Oxcarbazepine NDC 31722-025
Oxcarbazepine 600 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-025-01 | 31722002501 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-025-01)Marketed from Jan 11, 2022 | |
| 31722-025-05 | 31722002505 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-025-05)Marketed from Mar 10, 2023 | |
| 31722-025-10 | 31722002510 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-025-10)Marketed from Mar 10, 2023 | |
| 31722-025-31 | 31722002531 | 10 BLISTER PACK in 1 CARTON (31722-025-31) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 11, 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)
- Oxcarbazepine
- Generic name (nonproprietary)
- oxcarbazepine
- Active ingredients
- Oxcarbazepine — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215939
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 31722-025_4998217b-01c6-d647-e063-6294a90a2ff9SPL ID 4998217b-01c6-d647-e063-6294a90a2ff9SPL set ID fe49a773-562c-4da6-96b7-bba52f4d61e2RxCUI 312136, 312137, 312138UNII VZI5B1W380UPC 0331722023054, 0331722024051, 0331722025058
- 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
N431722002501followed by a unit qualifier and the quantityPackage 31722-0025-01. 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)
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 to 16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215939
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 300 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-2084 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-271 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-272 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3921 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3925 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3940 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-209 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-679 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-680 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-681 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-711 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-722 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2139 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2138 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-733 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2548 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-208 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-023 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-024 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-284 |
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