Oxcarbazepine
- Product NDC
- 60290-068
- 11-digit product format
- 602900068
- Labeler code
- 60290
- Product ID
- 60290-068_5111d6a1-5399-6f6b-e063-6294a90a6124
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Umedica Laboratories USA Inc.
- Application
- ANDA218341
- Marketing category
- ANDA
- Marketing start
- 2026-01-01
- 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
- 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 | 300 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 |
|---|
| 60290-068-01 | Oxcarbazepine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 60290-068-02 | Oxcarbazepine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60290-068-01 | 60290006801 | 100 TABLET, FILM COATED in 1 BOTTLE (60290-068-01) | 2026-01-01 | No | No | Historical |
| 60290-068-02 | 60290006802 | 500 TABLET, FILM COATED in 1 BOTTLE (60290-068-02) | 2026-01-01 | No | No | Historical |