FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68135-927DDiscontinued by firm2026-08-11
excluded packagepackage68135-92768135-927-48DDiscontinued by firm2026-08-11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-927-01ROCTAVIAN8 mL in 1 VIALINJECTION, SUSPENSION820
68135-927-48ROCTAVIAN1 in 1 CARTONINJECTION, SUSPENSION120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68135-927-01EA - Each68135-927d9934110-7a43-4805-ada8-c26c6d0f9da712023-08-08
68135-927-48EA - Each68135-9277b280f62-6804-4a96-942b-db7ab89167a112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-927ROCTAVIAN (VALOCTOCOGENE ROXAPARVOVEC-RVOX) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.]15Current NDC, 2 package rows20240307_0dcf7185-8e1c-456a-9d4e-7cc316400118.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125720Roctavianvaloctocogene roxaparvovec-rvox351(a)Disc2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68135-927-01681350927018 mL in 1 VIAL8 mlHistorical
68135-927-48681350927481 VIAL in 1 CARTON (68135-927-48) / 8 mL in 1 VIAL (68135-927-01) 1 vial2023-06-292026-05-29NoNoHistorical