Lyfgenia
- Product NDC
- 73554-1111
- 11-digit product format
- 735541111
- Labeler code
- 73554
- Product ID
- 73554-1111_35e89ce3-d947-47dc-971c-8450f3afe4a8
- Type
- CELLULAR THERAPY
- Nonproprietary name
- lovotibeglogene autotemcel
- Dosage form
- SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Genetix Biotherapeutics Inc.
- Application
- BLA125788
- Marketing category
- BLA
- Marketing start
- 2023-12-08
- Substance
- LOVOTIBEGLOGENE AUTOTEMCEL
- Active strength
- 20000000 1/20mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lyfgenia
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOVOTIBEGLOGENE AUTOTEMCEL | 20000000 1/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2C6A9NH2Z8 |
| Rxcui | 2672691, 2672697 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73554-1111-1 | Lyfgenia | 1 mL in 1 BAG | SUSPENSION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73554-1111 | LYFGENIA (LOVOTIBEGLOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.] | 5 | Current NDC, 1 package rows | 20240907_0d1b475e-5781-2bd1-e063-6294a90a7311.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2672691 | lovotibeglogene autotemcel 20,000,000 CELLS/ML in 20 ML Injection | PSN | 0d1b475e-5781-2bd1-e063-6294a90a7311 | 7 |
| 2672697 | lyfgenia 20,000,000 CELLS/ML in 20 ML Injection | PSN | 0d1b475e-5781-2bd1-e063-6294a90a7311 | 7 |
| 2672697 | 20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia] | SBD | 0d1b475e-5781-2bd1-e063-6294a90a7311 | 7 |
| 2672691 | 20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection | SCD | 0d1b475e-5781-2bd1-e063-6294a90a7311 | 7 |
| 2672691 | lovotibeglogene autotemcel 20,000,000 CELLS/ML per 20 ML Injection | SY | 0d1b475e-5781-2bd1-e063-6294a90a7311 | 7 |
| 2672697 | Lyfgenia 20,000,000 CELLS/ML per 20 ML Injection | SY | 0d1b475e-5781-2bd1-e063-6294a90a7311 | 7 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 73554-1111-1 | 73554111101 | 1 mL in 1 BAG (73554-1111-1) | 1 ml | 2023-12-08 | No | No | Historical |