CARNEXIV
- Product NDC
- 67386-621
- 11-digit product format
- 673860621
- Labeler code
- 67386
- Product ID
- 67386-621_d4a2d8e6-a918-4cfe-a9cf-195ab73c7587
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Lundbeck Pharmaceuticals LLC
- Application
- NDA206030
- Marketing category
- NDA
- Marketing start
- 2014-10-21
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 67386-621 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 67386-621 | 67386-621-52 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N206030-001 | CARNEXIV | CARBAMAZEPINE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | | RLD | 2016-10-07 |
Orange Book patents#
Application-product, Patent, Expiration table| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|
| N206030-001 | 9629797 | 2028-11-10 | U-2004 | | 2017-05-10 |
| N206030-001 | 9629797 | 2028-11-10 | U-2005 | | 2017-05-10 |
| N206030-001 | 9629797 | 2028-11-10 | U-2006 | | 2017-05-10 |
| N206030-001 | 9770407 | 2028-11-10 | | Drug product | 2017-10-04 |
| N206030-001 | 7635773 | 2029-03-13 | | Drug product | 2016-10-18 |
| N206030-001 | 8410077 | 2029-03-13 | | Drug product | 2016-10-18 |
| N206030-001 | 9750822 | 2029-03-13 | | Drug product | 2017-10-27 |
| N206030-001 | 9493582 | 2033-02-27 | | Drug product | 2016-12-08 |
| N206030-001 | 11529357 | 2040-01-31 | | Drug product | 2023-01-17 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67386-621-52 | 67386062152 | 1 VIAL, GLASS in 1 CARTON (67386-621-52) > 20 mL in 1 VIAL, GLASS | 2014-10-21 | 0000-00-00 | No | No | Current |