Skysona
- Product NDC
- 73554-2111
- 11-digit product format
- 735542111
- Labeler code
- 73554
- Product ID
- 73554-2111_1204fe44-ece9-4967-a7df-f005e166ac75
- Type
- CELLULAR THERAPY
- Nonproprietary name
- elivaldogene autotemcel
- Dosage form
- SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Genetix Biotherapeutics Inc.
- Application
- BLA125755
- Marketing category
- BLA
- Marketing start
- 2022-09-16
- Substance
- ELIVALDOGENE AUTOTEMCEL
- Active strength
- 30000000 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
- Skysona
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELIVALDOGENE AUTOTEMCEL | 30000000 1/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KUM75TD6SG |
| Rxcui | 2612552, 2612558 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73554-2111-1 | Skysona | 1 in 1 BAG | SUSPENSION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73554-2111 | SKYSONA (ELIVALDOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240418_f189502b-dc44-4289-99a6-cfba36918329.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2612552 | elivaldogene autotemcel 30,000,000 CELLS/mL in 20 ML Injection | PSN | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
| 2612558 | skysona 30,000,000 CELLS/mL in 20 ML Injection | PSN | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
| 2612558 | 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection [Skysona] | SBD | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
| 2612552 | 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection | SCD | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
| 2612558 | 20 ML Skysona 30000000 CELLS/ML Injection | SY | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
| 2612552 | elivaldogene autotemcel 30,000,000 CELLS/ML per 20 ML Injection | SY | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
| 2612558 | Skysona 30,000,000 CELLS/ML per 20 ML Injection | SY | f189502b-dc44-4289-99a6-cfba36918329 | 12 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73554-2111-1 | 73554211101 | 1 SUSPENSION in 1 BAG (73554-2111-1) | 1 suspension | 2022-09-16 | 0000-00-00 | No | No | Current |