Zynteglo
- Product NDC
- 73554-3111
- 11-digit product format
- 735543111
- Labeler code
- 73554
- Product ID
- 73554-3111_4a19a489-b94a-4a85-b094-0b6e9e3a6cd9
- Type
- CELLULAR THERAPY
- Nonproprietary name
- betibeglogene autotemcel
- Dosage form
- SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Genetix Biotherapeutics Inc.
- Application
- BLA125717
- Marketing category
- BLA
- Marketing start
- 2022-08-17
- Substance
- BETIBEGLOGENE AUTOTEMCEL
- Active strength
- 20000000 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
- Zynteglo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETIBEGLOGENE AUTOTEMCEL | 20000000 1/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MEE8487RTP |
| Rxcui | 2610435, 2610436 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73554-3111-1 | Zynteglo | 1 in 1 BAG | SUSPENSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73554-3111 | ZYNTEGLO (BETIBEGLOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231207_86931613-c262-47f5-8202-bc31fa69ad3d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73554-3111-1 | 73554311101 | 1 SUSPENSION in 1 BAG (73554-3111-1) | 1 suspension | 2022-08-17 | 0000-00-00 | No | No | Current |