Oxcarbazepine
- Product NDC
- 71335-2548
- 11-digit product format
- 713352548
- Labeler code
- 71335
- Product ID
- 71335-2548_99a631d2-4db5-4d59-9d54-a6334d7b9fac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215939
- Marketing category
- ANDA
- Marketing start
- 2022-01-11
- Substance
- OXCARBAZEPINE
- Active strength
- 300 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
openFDA Listing Details
- Product ID
- 71335-2548_99a631d2-4db5-4d59-9d54-a6334d7b9fac
- SPL ID
- 99a631d2-4db5-4d59-9d54-a6334d7b9fac
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Oxcarbazepine
- Generic name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2022-01-11
- Marketing category
- ANDA
- Application number
- ANDA215939
- Pharmacologic classes
- Anti-epileptic Agent [EPC]; Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| OXCARBAZEPINE | 300 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 312137 |
| Spl Set Id | 23137a89-cbd0-4a5f-8220-f26b7ba54330 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2548-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2548-1) | 2025-01-21 | No |
| 71335-2548-2 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2548-2) | 2025-01-21 | No |
| 71335-2548-3 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2548-3) | 2025-01-21 | No |
| 71335-2548-4 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2548-4) | 2025-01-21 | No |
| 71335-2548-5 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2548-5) | 2025-01-21 | No |
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 |
|---|
| 71335-2548-1 | 71335254801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2548-1) | 2025-01-21 | No | No | Historical |
| 71335-2548-2 | 71335254802 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2548-2) | 2025-01-21 | No | No | Historical |
| 71335-2548-3 | 71335254803 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2548-3) | 2025-01-21 | No | No | Historical |
| 71335-2548-4 | 71335254804 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2548-4) | 2025-01-21 | No | No | Historical |
| 71335-2548-5 | 71335254805 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2548-5) | 2025-01-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Oxcarbazepine | Bryant Ranch Prepack | 2025-01-21 | HUMAN PRESCRIPTION DRUG LABEL | 1 |