OXCARBAZEPINE
- Product NDC
- 70518-4480
- 11-digit product format
- 705184480
- Labeler code
- 70518
- Product ID
- 70518-4480_41ec4523-7a92-5280-e063-6294a90a6942
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078069
- Marketing category
- ANDA
- Marketing start
- 2025-09-13
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4480-0 | 70518448000 | 100 POUCH in 1 BOX (70518-4480-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4480-1) | 100 pouch | 2025-09-13 | No | No | Historical |
| 70518-4480-2 | 70518448002 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4480-2) | | 2025-10-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| OXCARBAZEPINE | REMEDYREPACK INC. | 2025-10-24 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| OXCARBAZEPINE | REMEDYREPACK INC. | 2025-09-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |