ocrevus zunovo

Generic: ocrelizumab and hyaluronidase

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ocrevus zunovo
Generic Name ocrelizumab and hyaluronidase
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

hyaluronidase (human recombinant) 23000 U/23mL, ocrelizumab 920 mg/23mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-554
Product ID 50242-554_3ec82250-b360-43e5-8d94-b4c36a0542a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761371
Listing Expiration 2026-12-31
Marketing Start 2024-09-13

Pharmacologic Class

Established (EPC)
endoglycosidase [epc] cd20-directed cytolytic antibody [epc]
Mechanism of Action
cd20-directed antibody interactions [moa]
Chemical Structure
glycoside hydrolases [cs] antibodies, monoclonal [cs] antibodies, monoclonal, humanized [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242554
Hyphenated Format 50242-554

Supplemental Identifiers

RxCUI
2693458 2693465
UNII
743QUY4VD8 A10SJL62JY
NUI
N0000175531 M0009499 N0000175078 N0000175657 M0001357 M0556300

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ocrevus zunovo (source: ndc)
Generic Name ocrelizumab and hyaluronidase (source: ndc)
Application Number BLA761371 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 23000 U/23mL
  • 920 mg/23mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-554-01) / 23 mL in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86) / 23 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

50242-554-01 1 VIAL, SINGLE-USE in 1 CARTON (50242-554-01) / 23 mL in 1 VIAL, SINGLE-USE 50242-554-86 1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86) / 23 mL in 1 VIAL, SINGLE-USE

Ingredients (2)

hyaluronidase (human recombinant) (23000 U/23mL) ocrelizumab (920 mg/23mL)

Linked Drug Pages (1)

Ocrevus Zunovo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "3ec82250-b360-43e5-8d94-b4c36a0542a8", "openfda": {"nui": ["N0000175531", "M0009499", "N0000175078", "N0000175657", "M0001357", "M0556300"], "unii": ["743QUY4VD8", "A10SJL62JY"], "rxcui": ["2693458", "2693465"], "spl_set_id": ["b216af61-99d0-42a3-afc2-b5bf86df1ec0"], "pharm_class_cs": ["Glycoside Hydrolases [CS]", "Antibodies, Monoclonal [CS]", "Antibodies, Monoclonal, Humanized [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]", "CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-554-01)  / 23 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-554-01", "marketing_start_date": "20240913"}, {"sample": true, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86)  / 23 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-554-86", "marketing_start_date": "20240913"}], "brand_name": "Ocrevus Zunovo", "product_id": "50242-554_3ec82250-b360-43e5-8d94-b4c36a0542a8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Antibodies", "Monoclonal", "Humanized [CS]", "CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]", "Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "50242-554", "generic_name": "ocrelizumab and hyaluronidase", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ocrevus Zunovo", "active_ingredients": [{"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "23000 U/23mL"}, {"name": "OCRELIZUMAB", "strength": "920 mg/23mL"}], "application_number": "BLA761371", "marketing_category": "BLA", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}