OXCARBAZEPINE
- Product NDC
- 31722-687
- 11-digit product format
- 317220687
- Labeler code
- 31722
- Product ID
- 31722-687_52678152-7684-aa17-e063-6394a90a5ff3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA216749
- Marketing category
- ANDA
- Marketing start
- 2023-10-20
- Substance
- OXCARBAZEPINE
- Active strength
- 60 mg/mL
- 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 | 60 mg/mL |
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 |
|---|
| 31722-687-25 | OXCARBAZEPINE | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 3 |
| 31722-687-25 | OXCARBAZEPINE | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-687 | OXCARBAZEPINE (OXCARBAZEPINE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250213_a18f591b-587e-4769-8ac2-9cfba0b82526.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 |
|---|
| 31722-687-25 | 31722068725 | 1 BOTTLE in 1 CARTON (31722-687-25) / 250 mL in 1 BOTTLE | 1 bottle | 2023-10-20 | No | No | Current |