FDA.reportPublic FDA data

Ocrevus Zunovo

Product NDC
50242-554
11-digit product format
502420554
Labeler code
50242
Product ID
50242-554_31e224c7-7f86-4fd4-8f6c-34a80a099ce4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ocrelizumab and hyaluronidase
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761371
Marketing category
BLA
Marketing start
2024-09-13
Substance
OCRELIZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength
920; 23000 mg/23mL; U/23mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [CS], CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ocrevus Zunovo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCRELIZUMAB920 mg/23mL
HYALURONIDASE (HUMAN RECOMBINANT)23000 U/23mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
0370057a-6e63-432c-842f-2aeb7aad1b53Product name120170613
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-554-01Ocrevus Zunovo1 in 1 CARTONINJECTION, SOLUTION19
50242-554-01Ocrevus Zunovo23 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION239
50242-554-86Ocrevus Zunovo23 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION239
50242-554-86Ocrevus Zunovo1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-554-01ML - Milliliter50242-554d48b7c8f-3643-4419-aff0-0ffa7d699b5912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-554OCREVUS ZUNOVO (OCRELIZUMAB AND HYALURONIDASE) INJECTION, SOLUTION [GENENTECH, INC.]5Current NDC, 4 package rows20241127_b216af61-99d0-42a3-afc2-b5bf86df1ec0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ocrevus ZunovoOCRELIZUMAB AND HYALURONIDASEGenentech, Inc.b216af61-99d0-42a3-afc2-b5bf86df1ec02026-08-17Warnings, Adverse reactionsExact identifier
application number: BLA761371
ndc (product): 50242-554

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761371Ocrevus Zunovoocrelizumab and hyaluronidase-ocsq351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2693458ocrelizumab-ocsq 920 MG / hyaluronidase-ocsq 23,000 UNT in 23 ML InjectionPSNb216af61-99d0-42a3-afc2-b5bf86df1ec09
2693465Ocrevus Zunovo 920 MG / 23,000 UNT in 23 ML InjectionPSNb216af61-99d0-42a3-afc2-b5bf86df1ec09
269346523 ML hyaluronidase-ocsq 1000 UNT/ML / ocrelizumab-ocsq 40 MG/ML Injection [Ocrevus Zunovo]SBDb216af61-99d0-42a3-afc2-b5bf86df1ec09
269345823 ML hyaluronidase-ocsq 1000 UNT/ML / ocrelizumab-ocsq 40 MG/ML InjectionSCDb216af61-99d0-42a3-afc2-b5bf86df1ec09
2693458ocrelizumab-hyaluronidase-ocsq 920 MG / 23,000 UNT per 23 ML InjectionSYb216af61-99d0-42a3-afc2-b5bf86df1ec09
2693458ocrelizumab-ocsq 920 MG / hyaluronidase-ocsq 23,000 UNT per 23 ML InjectionSYb216af61-99d0-42a3-afc2-b5bf86df1ec09
2693465Ocrevus Zunovo (ocrelizumab-hyaluronidase-ocsq 920 MG / 23,000 UNT) per 23 ML InjectionSYb216af61-99d0-42a3-afc2-b5bf86df1ec09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50242-554-01502420554011 VIAL, SINGLE-USE in 1 CARTON (50242-554-01) / 23 mL in 1 VIAL, SINGLE-USE2024-09-13NoNoCurrent
50242-554-86502420554861 VIAL, SINGLE-USE in 1 CARTON (50242-554-86) / 23 mL in 1 VIAL, SINGLE-USE2024-09-13YesNoCurrent