Prescription drug · ANDA
Oxcarbazepine NDC 67046-1640
Oxcarbazepine 300 mg/1 · Tablet, Film coated · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1640-3 | 67046164003 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1640-3)Marketed from Jan 6, 2026 |
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
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078005
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 67046-1640_47b9209b-398e-1d7a-e063-6394a90a4adcSPL ID 47b9209b-398e-1d7a-e063-6394a90a4adcSPL set ID 47b92168-6832-1e0b-e063-6394a90a079aRxCUI 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
N467046164003followed by a unit qualifier and the quantityPackage 67046-1640-03. 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.
About NDC 67046-1640
- What is NDC 67046-1640?
- 67046-1640 is the product NDC for Oxcarbazepine, Oxcarbazepine 300 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxcarbazepine.
- What is the active ingredient?
- Oxcarbazepine.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxcarbazepine?
- 118 other product NDCs are listed under this name. See all Oxcarbazepine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxcarbazepine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-172 | 90096-0172-01 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-171 | 90096-0171-01 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-173 | 90096-0173-01 |
| Oxcarbazepine | Oxcarbazepine 300 mg/5mL | SuspensionOral | Novadoz Pharmaceuticals LLC | 72205-354 | 72205-0354-85 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4664 | 70518-4664-0070518-4664-01 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4663 | 70518-4663-0070518-4663-01 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-2084 | 67046-2084-03 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0868 | 67046-0868-03 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0179 | 67046-0179-03 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7593 | 00904-7593-61 |
Other NDCs under ANDA 078005
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8635 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8636 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-220 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-221 |
| Oxcarbazepine | Oxcarbazepine 600 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-222 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8634 |