Zolgensma
- Product NDC
- 71894-148
- 11-digit product format
- 718940148
- Labeler code
- 71894
- Product ID
- 71894-148_f1dde092-6024-41c8-8006-77e19ef21ec1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- onasemnogene abeparvovec-xioi
- Dosage form
- KIT
- Labeler
- Novartis Gene Therapies, Inc.
- Application
- BLA125694
- Marketing category
- BLA
- Marketing start
- 2019-05-24
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71894-148_f1dde092-6024-41c8-8006-77e19ef21ec1
- SPL ID
- f1dde092-6024-41c8-8006-77e19ef21ec1
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Zolgensma
- Generic name
- onasemnogene abeparvovec-xioi
- Dosage form
- KIT
- Marketing start
- 2019-05-24
- Marketing category
- BLA
- Application number
- BLA125694
- Listing expiration
- 2026-12-31
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Rxcui | 797544, 2170239, 2170241, 2170244, 2170245, 2170246, 2170247, 2170248, 2170249, 2170250, 2170251, 2170252, 2170253, 2170254, 2170255, 2170256, 2170257, 2170258, 2170259, 2170260 |
| Spl Set Id | 68cd4f06-70e1-40d8-bedb-609ec0afa471 |
| Manufacturer Name | Novartis Gene Therapies, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71894-148-12 | 1 KIT in 1 CARTON (71894-148-12) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01) | 2023-02-16 | No |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71894-148-12 | 71894014812 | 1 KIT in 1 CARTON (71894-148-12) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01) | 1 kit | 2023-02-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zolgensma | Novartis Gene Therapies, Inc. | 2025-12-18 | HUMAN PRESCRIPTION DRUG LABEL | 14 |