LUXTURNA
- Product NDC
- 71394-415
- 11-digit product format
- 713940415
- Labeler code
- 71394
- Product ID
- 71394-415_173eb100-b8ab-4255-bad7-466d01195c6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- voretigene neparvovec-rzyl
- Dosage form
- KIT
- Labeler
- Spark Therapeutics, Inc.
- Application
- BLA125610
- Marketing category
- BLA
- Marketing start
- 2017-12-19
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUXTURNA
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 1995884, 1995886 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71394-065-01 | LUXTURNA | 1 in 1 VIAL, PLASTIC | INJECTION, SUSPENSION | 1 | 0.05 mg | 13 |
| 71394-415-01 | LUXTURNA | 1 in 1 CARTON | KIT | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71394-415 | LUXTURNA (VORETIGENE NEPARVOVEC-RZYL) KIT [SPARK THERAPEUTICS, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240418_08313a24-e7ce-457a-bb3f-161bc45517ee.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1995886 | Luxturna 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection | PSN | 08313a24-e7ce-457a-bb3f-161bc45517ee | 13 |
| 1995884 | voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection | PSN | 08313a24-e7ce-457a-bb3f-161bc45517ee | 13 |
| 1995886 | 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection [Luxturna] | SBD | 08313a24-e7ce-457a-bb3f-161bc45517ee | 13 |
| 1995884 | 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection | SCD | 08313a24-e7ce-457a-bb3f-161bc45517ee | 13 |
| 1995886 | Luxturna 5,000,000,000,000 VECTOR-GENOMES/ML per 0.5 ML Injection | SY | 08313a24-e7ce-457a-bb3f-161bc45517ee | 13 |
| 1995884 | voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML per 0.5 ML Injection | SY | 08313a24-e7ce-457a-bb3f-161bc45517ee | 13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71394-065-01 | 71394006501 | 1 in 1 VIAL, PLASTIC | | | | | | Historical |
| 71394-415-01 | 71394041501 | 1 KIT in 1 CARTON (71394-415-01) * 1 INJECTION, SUSPENSION in 1 VIAL, PLASTIC (71394-065-01) * 1 INJECTION, SOLUTION in 1 VIAL, PLASTIC (71394-716-01) | 1 kit | 2017-12-19 | 0000-00-00 | No | No | Current |