OCREVUS: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 300 mg/10 mL Vial Carton

NDC 50242-150-01

Ocrevus®
(ocrelizumab)
Injection

300 mg/10 mL
(30 mg/mL)

For Intravenous Infusion.
Must Be Diluted.

Single-Dose Vial.
Discard Unused Portion.

Attention Pharmacist: Dispense the
accompanying Medication Guide to each patient.

Rx only

1 vial

Genentech

10233065

PRINCIPAL DISPLAY PANEL -- 300 mg/10 mL Vial Carton
(click image for full-size original)
OCREVUS ocrelizumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-150
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCRELIZUMAB (OCRELIZUMAB) OCRELIZUMAB 300 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE 21.4 mg in 10 mL
ACETIC ACID 2.5 mg in 10 mL
TREHALOSE DIHYDRATE 400 mg in 10 mL
POLYSORBATE 20 2 mg in 10 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-150-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 10 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-150-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761053 03/28/2017
Labeler — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 485244961 MANUFACTURE (50242-150), ANALYSIS (50242-150), LABEL (50242-150), PACK (50242-150)
Establishment
Name Address ID/FEI Operations
Roche Singapore Technical Operations Pte. Ltd. 937189173 ANALYSIS (50242-150), API MANUFACTURE (50242-150)
Establishment
Name Address ID/FEI Operations
Roche Diagnostics GmbH 315028860 ANALYSIS (50242-150), MANUFACTURE (50242-150), PACK (50242-150)
Establishment
Name Address ID/FEI Operations
Roche Diagnostics GmbH 323105205 ANALYSIS (50242-150)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 080129000 ANALYSIS (50242-150)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 146373191 ANALYSIS (50242-150)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 004074162 ANALYSIS (50242-150), API MANUFACTURE (50242-150)

Revised: 03/2023 Genentech, Inc.

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