Prescription drug · ANDA
Oxcarbazepine NDC 50742-611
Oxcarbazepine 150 mg/1 · Tablet, Extended release · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-611-01 | 50742061101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-611-01)Marketed from Jun 1, 2025 |
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 — 150 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215796
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50742-611_69d2a354-3ced-494f-bda2-f3f5c4635eaaSPL ID 69d2a354-3ced-494f-bda2-f3f5c4635eaaSPL set ID 70798ca9-0eda-49c0-8a7c-b775b6ae3d69RxCUI 1365653, 1365842, 1365844UNII VZI5B1W380UPC 0350742611010, 0350742612017, 0350742613014
- 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
N450742061101followed by a unit qualifier and the quantityPackage 50742-0611-01. 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 extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215796
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, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-612 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-613 |