CASGEVY
- Product NDC
- 51167-290
- 11-digit product format
- 511670290
- Labeler code
- 51167
- Product ID
- 51167-290_524ddbe0-e4ac-4619-afc1-b5829bf8394c
- Type
- CELLULAR THERAPY
- Nonproprietary name
- exagamglogene autotemcel
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Vertex Pharmaceuticals Incorporated
- Application
- BLA125787
- Marketing category
- BLA
- Marketing start
- 2023-12-08
- Substance
- EXAGAMGLOGENE AUTOTEMCEL
- Active strength
- 13000000 1/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CASGEVY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EXAGAMGLOGENE AUTOTEMCEL | 13000000 1/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S53L777GM8 |
| Rxcui | 2671671, 2671677 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51167-290-01 | CASGEVY | 20 mL in 1 VIAL | INJECTION, SUSPENSION | 20 | | 13 |
| 51167-290-09 | CASGEVY | 9 in 1 CARTON | INJECTION, SUSPENSION | 9 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51167-290 | CASGEVY (EXAGAMGLOGENE AUTOTEMCEL) INJECTION, SUSPENSION [VERTEX PHARMACEUTICALS INCORPORATED] | 6 | Current NDC, 2 package rows | 20240823_7c3e12ad-e2fe-4d3f-a630-ea7364d9e846.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2671677 | casgevy 13,000,000 CELLS/mL in 1.5 ML Injection | PSN | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
| 2671671 | exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection | PSN | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
| 2671677 | 1.5 ML exagamglogene autotemcel 13000000 CELLS/ML Injection [Casgevy] | SBD | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
| 2671671 | 1.5 ML exagamglogene autotemcel 13000000 CELLS/ML Injection | SCD | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
| 2671677 | 1.5 ML Casgevy 13000000 CELLS/ML Injection | SY | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
| 2671677 | Casgevy 13,000,000 CELLS/ML per 1.5 ML Injection | SY | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
| 2671671 | exagamglogene autotemcel 13,000,000 CELLS/ML per 1.5 ML Injection | SY | 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 | 13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51167-290-01 | 51167029001 | 20 mL in 1 VIAL | 20 ml | | | | Historical |
| 51167-290-09 | 51167029009 | 9 VIAL in 1 CARTON (51167-290-09) / 20 mL in 1 VIAL (51167-290-01) | 9 vial | 2023-12-08 | No | No | Current |