Prescription drug · ANDA
Oxcarbazepine NDC 72888-089
Oxcarbazepine 600 mg/1 · Tablet, Film coated · Oral · Advagen Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-089-01 | 7288800890172888008901 | 100 TABLET, FILM COATED in 1 BOTTLE (72888-089-01)Marketed from Mar 19, 2021 | |
| 72888-089-05 | 7288800890572888008905 | 500 TABLET, FILM COATED in 1 BOTTLE (72888-089-05)Marketed from Mar 19, 2021 | |
| 72888-089-30 | 7288800893072888008930 | 30 TABLET, FILM COATED in 1 BOTTLE (72888-089-30)Marketed from Mar 19, 2021 |
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
- Advagen Pharma LimitedNDC labeler code 72888
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077747
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72888-089_4b920b8e-b260-b6a0-e063-6294a90a3490SPL ID 4b920b8e-b260-b6a0-e063-6294a90a3490SPL set ID b0bc10f0-7d1b-4adc-bc59-c48dab58ee5aRxCUI 312136, 312137, 312138UNII VZI5B1W380UPC 0372888088303, 0372888088013, 0372888089058, 0372888089300, 0372888087016, 0372888087054, 0372888088051, 0372888087306, 0372888089010
- 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
N472888008901followed by a unit qualifier and the quantityPackage 72888-0089-01. 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 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 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 72888-089
- What is NDC 72888-089?
- 72888-089 is the product NDC for Oxcarbazepine, Oxcarbazepine 600 mg/1 tablet, film coated, listed with the FDA by Advagen Pharma Limited. It has 3 package NDCs, 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?
- Advagen Pharma Limited, NDC labeler code 72888. 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 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 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 077747
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 150 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-087 |
| Oxcarbazepine | Oxcarbazepine 300 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-088 |