OXCARBAZEPINE
- Product NDC
- 72888-074
- 11-digit product format
- 728880074
- Labeler code
- 72888
- Product ID
- 72888-074_4844e056-6c56-1482-e063-6394a90a018e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd
- Application
- ANDA215726
- Marketing category
- ANDA
- Marketing start
- 2022-08-31
- Substance
- OXCARBAZEPINE
- Active strength
- 300 mg/5mL
- 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/5mL |
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 |
|---|
| 72888-074-14 | OXCARBAZEPINE | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
| 72888-074-14 | OXCARBAZEPINE | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-074 | OXCARBAZEPINE SUSPENSION [ADVAGEN PHARMA LTD] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240717_4ef6a941-a017-40f2-a50a-ab66c43b3347.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 |
|---|
| 72888-074-14 | 72888007414 | 1 BOTTLE in 1 CARTON (72888-074-14) / 250 mL in 1 BOTTLE | 1 bottle | 2024-02-14 | 0000-00-00 | No | No | Current |