ocrevus

Generic: ocrelizumab

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

Drug Facts

Product Profile

Brand Name ocrevus
Generic Name ocrelizumab
Labeler genentech, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ocrelizumab 300 mg/10mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-150
Product ID 50242-150_38590bd9-ff82-44dc-98aa-ed5936351017
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761053
Listing Expiration 2026-12-31
Marketing Start 2017-03-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242150
Hyphenated Format 50242-150

Supplemental Identifiers

RxCUI
1876380 1876385
UNII
A10SJL62JY
NUI
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 (source: ndc)
Generic Name ocrelizumab (source: ndc)
Application Number BLA761053 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-150-01) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

50242-150-01 1 VIAL, SINGLE-USE in 1 CARTON (50242-150-01) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

ocrelizumab (300 mg/10mL)

Linked Drug Pages (1)

OCREVUS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "38590bd9-ff82-44dc-98aa-ed5936351017", "openfda": {"nui": ["N0000175078", "N0000175657", "M0001357", "M0556300"], "unii": ["A10SJL62JY"], "rxcui": ["1876380", "1876385"], "spl_set_id": ["9da42362-3bb5-4b83-b4bb-b59fd4e55f0d"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]", "Antibodies, Monoclonal, Humanized [CS]"], "pharm_class_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 (50242-150-01)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-150-01", "marketing_start_date": "20170328"}], "brand_name": "OCREVUS", "product_id": "50242-150_38590bd9-ff82-44dc-98aa-ed5936351017", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Antibodies", "Monoclonal", "Humanized [CS]", "CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "50242-150", "generic_name": "ocrelizumab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OCREVUS", "active_ingredients": [{"name": "OCRELIZUMAB", "strength": "300 mg/10mL"}], "application_number": "BLA761053", "marketing_category": "BLA", "marketing_start_date": "20170328", "listing_expiration_date": "20261231"}