Rybrevant (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 7 mL Vial Carton

NDC 57894-501-01

Rybrevant®
(amivantamab-vmjw)
Injection

350 mg/7 mL
(50 mg/mL)

For Intravenous Infusion Only
Dilute Before Use

Rx only
7 mL Vial

janssen

Single-dose vial.Discard unused portion.

PRINCIPAL DISPLAY PANEL -- 7 mL Vial Carton
(click image for full-size original)
RYBREVANT amivantamab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-501
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amivantamab (Amivantamab) Amivantamab 350 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
METHIONINE
POLYSORBATE 20
sucrose
water
Product Characteristics
Color YELLOW (Colorlous to Pale Yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57894-501-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (57894-501-00)
1 NDC:57894-501-00 1 INJECTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (57894-501-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761210 05/21/2021
Labeler — Janssen Biotech, Inc. (099091753)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutical Sciences Unlimited Company 985639841 API MANUFACTURE (57894-501), ANALYSIS (57894-501)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 LABEL (57894-501), MANUFACTURE (57894-501), ANALYSIS (57894-501)

Revised: 11/2022 Janssen Biotech, Inc.

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