ROCTAVIAN
- Product NDC
- 68135-927
- 11-digit product format
- 681350927
- Labeler code
- 68135
- Product ID
- 68135-927_f29cbdac-52db-4736-8390-19503a9762d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valoctocogene roxaparvovec-rvox
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- BioMarin Pharmaceutical Inc.
- Application
- BLA125720
- Marketing category
- BLA
- Marketing start
- 2023-06-29
- Marketing end
- 2026-05-29
- Substance
- VALOCTOCOGENE ROXAPARVOVEC
- Active strength
- 20000000000000 {GC}/mL
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68135-927-01 | ROCTAVIAN | 8 mL in 1 VIAL | INJECTION, SUSPENSION | 8 | | 20 |
| 68135-927-48 | ROCTAVIAN | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68135-927 | ROCTAVIAN (VALOCTOCOGENE ROXAPARVOVEC-RVOX) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.] | 15 | Current NDC, 2 package rows | 20240307_0dcf7185-8e1c-456a-9d4e-7cc316400118.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68135-927-01 | 68135092701 | 8 mL in 1 VIAL | 8 ml | | | | | Historical |
| 68135-927-48 | 68135092748 | 1 VIAL in 1 CARTON (68135-927-48) / 8 mL in 1 VIAL (68135-927-01) | 1 vial | 2023-06-29 | 2026-05-29 | No | No | Historical |