OXCARBAZEPINE
- Product NDC
- 0904-7595
- 11-digit product format
- 009047595
- Labeler code
- 0904
- Product ID
- 0904-7595_d906c01f-3eb3-4d6b-b410-e913954a5458
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078069
- Marketing category
- ANDA
- Marketing start
- 2026-04-03
- 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 |
|---|
| 0904-7595-61 | OXCARBAZEPINE | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 2 |
| 0904-7595-61 | OXCARBAZEPINE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 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 |
|---|
| 0904-7595-61 | 00904759561 | 100 BLISTER PACK in 1 CARTON (0904-7595-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2026-04-03 | No | No | Historical |