Oxcarbazepine
- Product NDC
- 0615-8448
- 11-digit product format
- 006158448
- Labeler code
- 0615
- Product ID
- 0615-8448_a153bb37-3cb0-42aa-940b-234fd5df5c70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA215939
- Marketing category
- ANDA
- Marketing start
- 2022-01-11
- Marketing end
- 2026-07-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxcarbazepine
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 |
|---|
| 0615-8448-39 | Oxcarbazepine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8448 | OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 4 | Current NDC, 1 package rows | 20250226_3fb47782-3dfc-458c-92a6-493de1207c0e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8448-39 | 00615844839 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8448-39) | 2023-01-13 | 2026-07-31 | No | No | Historical |