OXCARBAZEPINE
- Product NDC
- 67046-1597
- 11-digit product format
- 670461597
- Labeler code
- 67046
- Product ID
- 67046-1597_3f15c6c5-e94e-3ebd-e063-6394a90af7d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA078069
- Marketing category
- ANDA
- Marketing start
- 2025-09-18
- Substance
- OXCARBAZEPINE
- Active strength
- 150 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1597-3 | 67046159703 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1597-3) | 2025-09-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| OXCARBAZEPINE | Coupler LLC | 2025-09-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |