20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
- RxCUI
- 2610436
- RxNorm name
- 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
- Display name
- 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
- Full name
- 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
- Term type
- SBD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:07
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125717 | Zynteglo | betibeglogene autotemcel | 351(a) | Rx | 2026-06-01 |
UNII Substances#
No records found.
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Zynteglo | BETIBEGLOGENE AUTOTEMCEL | Genetix Biotherapeutics Inc. | 86931613-c262-47f5-8202-bc31fa69ad3d | 2026-07-21 | Warnings, Adverse reactions | 2610436 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 86931613-c262-47f5-8202-bc31fa69ad3d | 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo] | SBD | 6 | These highlights do not include all the information needed to use ZYNTEGLO ® safely and effectively. See full prescribing information for ZYNTEGLO. ZYNTEGLO (betibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 2022 | 20260407 |
| 86931613-c262-47f5-8202-bc31fa69ad3d | 20 ML Zynteglo 20000000 CELLS/ML Injection | SY | 6 | These highlights do not include all the information needed to use ZYNTEGLO ® safely and effectively. See full prescribing information for ZYNTEGLO. ZYNTEGLO (betibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 2022 | 20260407 |
| 86931613-c262-47f5-8202-bc31fa69ad3d | zynteglo 20 ML Injection | PSN | 6 | These highlights do not include all the information needed to use ZYNTEGLO ® safely and effectively. See full prescribing information for ZYNTEGLO. ZYNTEGLO (betibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 2022 | 20260407 |