Oxcarbazepine
- Product NDC
- 50742-613
- 11-digit product format
- 507420613
- Labeler code
- 50742
- Product ID
- 50742-613_69d2a354-3ced-494f-bda2-f3f5c4635eaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA215796
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- 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
- 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 1365653, 1365842, 1365844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50742-613-01 | Oxcarbazepine | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50742-613-01 | 50742061301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-613-01) | 2025-06-01 | No | No | Current |