Oxcarbazepine
- Product NDC
- 50268-681
- 11-digit product format
- 502680681
- Labeler code
- 50268
- Product ID
- 50268-681_2b4c161c-f20b-38d5-e063-6394a90a8a79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA215939
- Marketing category
- ANDA
- Marketing start
- 2023-06-07
- Substance
- OXCARBAZEPINE
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| VZI5B1W380 | OXCARBAZEPINE | 28721-07-5 | OXCARBAZEPINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-681-15 | 50268068115 | 50 BLISTER PACK in 1 BOX (50268-681-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-681-11) | 50 blister pack | 2023-06-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Oxcarbazepine | AvPAK | 2025-01-09 | HUMAN PRESCRIPTION DRUG LABEL | 2 |