Oxcarbazepine
- Product NDC
- 42806-600
- 11-digit product format
- 428060600
- Labeler code
- 42806
- Product ID
- 42806-600_6c0be20f-c8ac-481a-ac8c-98894fc442d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- EPIC PHARMA, LLC
- Application
- ANDA215332
- Marketing category
- ANDA
- Marketing start
- 2023-01-30
- 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 |
|---|
| 42806-600-22 | Oxcarbazepine | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
| 42806-600-22 | Oxcarbazepine | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-600 | OXCARBAZEPINE SUSPENSION [EPIC PHARMA, LLC] | 3 | Current NDC, 2 package rows | 20250109_62ab716b-f05f-454d-95b3-1a382cdf7226.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42806-600-22 | 42806060022 | 1 BOTTLE in 1 CARTON (42806-600-22) / 250 mL in 1 BOTTLE | 1 bottle | 2023-01-30 | No | No | Historical |