Oxcarbazepine
- Product NDC
- 72888-461
- 11-digit product format
- 728880461
- Labeler code
- 72888
- Product ID
- 72888-461_49fe26b4-1dcb-832f-e063-6294a90a6195
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd.
- Application
- ANDA207717
- Marketing category
- ANDA
- Marketing start
- 2025-05-20
- Substance
- OXCARBAZEPINE
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxcarbazepine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXCARBAZEPINE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 312136, 312137, 312138 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-461-01 | Oxcarbazepine | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 72888-461-02 | Oxcarbazepine | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-461-01 | 72888046101 | 500 TABLET in 1 BOTTLE (72888-461-01) | 500 tablet | 2025-05-20 | No | No | Current |
| 72888-461-02 | 72888046102 | 100 TABLET in 1 BOTTLE (72888-461-02) | 100 tablet | 2025-05-20 | No | No | Current |