Prescription drug · ANDA
Oxcarbazepine NDC 67877-532
Oxcarbazepine 60 mg/mL · Suspension · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-532-58 | 67877053258 | 250 mL in 1 BOTTLE (67877-532-58)Marketed from Jan 1, 2020 |
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 — 60 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213183
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 67877-532_1f629ae0-1f1c-4bce-b216-af26d84d24c6SPL ID 1f629ae0-1f1c-4bce-b216-af26d84d24c6SPL set ID 3f36f519-c30c-4929-afa0-9844dc531e3fRxCUI 283536UNII VZI5B1W380UPC 0367877532585
- 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
N467877053258followed by a unit qualifier and the quantityPackage 67877-0532-58. 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 oral suspension 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. Oxcarbazepine oral suspension 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 67877-532
- What is NDC 67877-532?
- 67877-532 is the product NDC for Oxcarbazepine, Oxcarbazepine 60 mg/mL suspension, listed with the FDA by Ascend Laboratories, 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 600 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-173 | 90096-0173-01 |
| Oxcarbazepine | Oxcarbazepine 150 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-171 | 90096-0171-01 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-172 | 90096-0172-01 |
| 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 |