Oxcarbazepine
- Product NDC
- 82804-209
- 11-digit product format
- 828040209
- Labeler code
- 82804
- Product ID
- 82804-209_433d9d03-a36e-42c6-8e4d-f333ed60e45a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 312137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-209-72 | Oxcarbazepine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-209 | OXCARBAZEPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20250326_433d9d03-a36e-42c6-8e4d-f333ed60e45a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-209-72 | 82804020972 | 120 TABLET, FILM COATED in 1 BOTTLE (82804-209-72) | 2025-03-18 | No | No | Current |