Oxcarbazepine
- Product NDC
- 10135-798
- 11-digit product format
- 101350798
- Labeler code
- 10135
- Product ID
- 10135-798_38688247-8bdb-ee98-e063-6294a90a8ef6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc
- Application
- ANDA217782
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxcarbazepine
- Listing expiration
- 2026-12-31
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 |
|---|
| 10135-798-41 | Oxcarbazepine | 250 mL in 1 BOTTLE, GLASS | SUSPENSION | 250 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-798 | OXCARBAZEPINE SUSPENSION [MARLEX PHARMACEUTICALS, INC] | 1 | Current NDC, 1 package rows | 20250508_d3684d55-0564-4849-bdf6-b91f22a3e28c.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 |
|---|
| 10135-798-41 | 10135079841 | 250 mL in 1 BOTTLE, GLASS (10135-798-41) | 250 ml | 2025-05-01 | No | No | Current |