Oxcarbazepine
- Product NDC
- 70518-3921
- 11-digit product format
- 705183921
- Labeler code
- 70518
- Product ID
- 70518-3921_3646eab6-6f97-cf2b-e063-6294a90a1b93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215939
- Marketing category
- ANDA
- Marketing start
- 2023-11-22
- 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
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 312137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3921-0 | Oxcarbazepine | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 4 |
| 70518-3921-1 | Oxcarbazepine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3921 | OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20240723_0abe9478-4084-286d-e063-6294a90a9ba7.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 |
|---|
| 70518-3921-0 | 70518392100 | 100 POUCH in 1 BOX (70518-3921-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3921-1) | 100 pouch | 2023-11-22 | No | No | Historical |
| 70518-3921-1 | 70518392101 | 1 in 1 POUCH | | | | | Historical |