Prescription drug · ANDA
oxcarbazepine NDC 68382-693
Oxcarbazepine 600 mg/1 · Tablet · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-693-01 | 6838206930168382069301 | 100 TABLET in 1 BOTTLE (68382-693-01)Marketed from Jul 10, 2025 | |
| 68382-693-05 | 6838206930568382069305 | 500 TABLET in 1 BOTTLE (68382-693-05)Marketed from Jul 10, 2025 | |
| 68382-693-30 | 6838206933068382069330 | 10 BLISTER PACK in 1 CARTON (68382-693-30) / 10 TABLET in 1 BLISTER PACKMarketed from Jul 10, 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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211747
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68382-693_d5008577-1d35-4145-9536-6d6ded55342cSPL ID d5008577-1d35-4145-9536-6d6ded55342cSPL set ID 5048dc87-2d89-434d-be51-4a97b0ce0601RxCUI 312136, 312137, 312138UNII VZI5B1W380UPC 0368382692306, 0368382691309, 0368382693013, 0368382693303, 0368382692016, 0368382691019
- 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
N468382069301followed by a unit qualifier and the quantityPackage 68382-0693-01. 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: 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 ) 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.
Excerpt only. Read the full label for complete information.
About NDC 68382-693
- What is NDC 68382-693?
- 68382-693 is the product NDC for oxcarbazepine, Oxcarbazepine 600 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. 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?
- Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 211747
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 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-691 |
| oxcarbazepine | Oxcarbazepine 300 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-692 |
| oxcarbazepine | Oxcarbazepine 150 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1842 |
| oxcarbazepine | Oxcarbazepine 300 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1843 |
| oxcarbazepine | Oxcarbazepine 600 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1844 |