CARVYKTI
- Product NDC
- 57894-111
- 11-digit product format
- 578940111
- Labeler code
- 57894
- Product ID
- 57894-111_b911e9ec-28f1-4ddc-b0b9-49086f83300b
- Type
- CELLULAR THERAPY
- Nonproprietary name
- ciltacabtagene autoleucel
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA125746
- Marketing category
- BLA
- Marketing start
- 2022-02-28
- Substance
- CILTACABTAGENE AUTOLEUCEL
- Active strength
- 100000000 1/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CARVYKTI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CILTACABTAGENE AUTOLEUCEL | 100000000 1/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0L1F17908Q |
| Rxcui | 2594780, 2594786, 2594789, 2594792 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-111-01 | CARVYKTI | 1 in 1 BAG | INJECTION, SUSPENSION | 1 | | 17 |
| 57894-111-02 | CARVYKTI | 1 in 1 BAG | INJECTION, SUSPENSION | 1 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-111 | CARVYKTI (CILTACABTAGENE AUTOLEUCEL) INJECTION, SUSPENSION [JANSSEN BIOTECH, INC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240706_7d040b91-3fb8-41db-ba7f-60a36f06e2c2.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2594792 | CARVYKTI 100,000,000 CELLS in 30 ML Injection | PSN | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594786 | CARVYKTI 100,000,000 CELLS in 70 ML Injection | PSN | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594789 | ciltacabtagene autoleucel 100,000,000 CELLS in 30 ML Injection | PSN | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594780 | ciltacabtagene autoleucel 100,000,000 CELLS in 70 ML Injection | PSN | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594792 | 30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection [Carvykti] | SBD | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594786 | 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection [Carvykti] | SBD | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594789 | 30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection | SCD | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594780 | 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection | SCD | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594792 | 30 ML Carvykti 3330000 CELLS/ML Injection | SY | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594786 | 70 ML Carvykti 1430000 CELLS/ML Injection | SY | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594792 | Carvykti 100,000,000 CELLS per 30 ML Injection | SY | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594786 | Carvykti 100,000,000 CELLS per 70 ML Injection | SY | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594789 | ciltacabtagene autoleucel 100,000,000 CELLS per 30 ML Injection | SY | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
| 2594780 | ciltacabtagene autoleucel 100,000,000 CELLS per 70 ML Injection | SY | 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 | 17 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57894-111-01 | 57894011101 | 1 INJECTION, SUSPENSION in 1 BAG (57894-111-01) | 2022-02-28 | 0000-00-00 | No | No | Current |
| 57894-111-02 | 57894011102 | 1 INJECTION, SUSPENSION in 1 BAG (57894-111-02) | 2022-02-28 | 0000-00-00 | No | No | Current |