Prescription drug · ANDA
Oxcarbazepine NDC 62135-841
Oxcarbazepine 300 mg/5mL · Suspension · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-841-24 | 62135084124 | 20 CUP, UNIT-DOSE in 1 CARTON (62135-841-24) / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45)Marketed from Mar 27, 2024 | |
| 62135-841-54 | 62135084154 | 250 mL in 1 BOTTLE (62135-841-54)Marketed from Mar 27, 2024 |
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 — 300 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212428
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62135-841_47e4dcae-6305-e681-e063-6294a90a5359SPL ID 47e4dcae-6305-e681-e063-6294a90a5359SPL set ID c2affa00-1d57-4d85-8db3-745191b4714dRxCUI 283536UNII VZI5B1W380UPC 0362135841546
- 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
N462135084124followed by a unit qualifier and the quantityPackage 62135-0841-24. 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 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 212428
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/5mL | SuspensionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-841 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.