oxcarbazepine
- Product NDC
- 33342-259
- 11-digit product format
- 333420259
- Labeler code
- 33342
- Product ID
- 33342-259_962098cc-2d84-4723-a296-b110f1fd659e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxcarbazepine
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA207300
- Marketing category
- ANDA
- Marketing start
- 2025-07-11
- Substance
- OXCARBAZEPINE
- Active strength
- 300 mg/5mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- oxcarbazepine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXCARBAZEPINE | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 283536 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-259-67 | oxcarbazepine | 250 mL in 1 BOTTLE | FOR SUSPENSION | 250 | | 1 |
| 33342-259-67 | oxcarbazepine | 1 in 1 CARTON | FOR SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-259-67 | 33342025967 | 1 BOTTLE in 1 CARTON (33342-259-67) / 250 mL in 1 BOTTLE | 1 bottle | 2025-07-11 | No | No | Current |