Oxcarbazepine
- Product NDC
- 31722-024
- 11-digit product format
- 317220024
- Labeler code
- 31722
- Product ID
- 31722-024_4998217b-01c6-d647-e063-6294a90a2ff9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA215939
- Marketing category
- ANDA
- Marketing start
- 2022-01-11
- 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 |
|---|
| 31722-024-01 | Oxcarbazepine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 31722-024-05 | Oxcarbazepine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 31722-024-10 | Oxcarbazepine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
| 31722-024-31 | Oxcarbazepine | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 5 |
| 31722-024-31 | Oxcarbazepine | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-024 | OXCARBAZEPINE (OXCARBAZEPINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20250205_fe49a773-562c-4da6-96b7-bba52f4d61e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-024-01 | 31722002401 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-024-01) | | 2022-01-11 | 0000-00-00 | No | No | Current |
| 31722-024-05 | 31722002405 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-024-05) | | 2023-03-10 | | No | No | Current |
| 31722-024-10 | 31722002410 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-024-10) | | 2023-03-10 | | No | No | Current |
| 31722-024-31 | 31722002431 | 10 BLISTER PACK in 1 CARTON (31722-024-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2022-01-11 | 0000-00-00 | No | No | Current |