INFLIXIMAB (Page 13 of 13)

PRINCIPAL DISPLAY PANEL — 100 mg Vial Box

NDC 57894-160-01

Infliximab
for injection

100 mg per vial

Single-dose vial.
Discard unused portion.

Each patient is required to receive the enclosed
Medication Guide.

Must Reconstitute and Dilute Before Intravenous
Infusion.
Must infuse over at least 2 hours with an in-line filter.

Rx only

PRINCIPAL DISPLAY PANEL -- 100 mg Vial Box
(click image for full-size original)
INFLIXIMAB infliximab injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-160
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLIXIMAB (INFLIXIMAB) INFLIXIMAB 100 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
sucrose 500 mg in 10 mL
polysorbate 80 0.5 mg in 10 mL
sodium phosphate, monobasic, monohydrate 2.2 mg in 10 mL
sodium phosphate, dibasic, dihydrate 6.1 mg in 10 mL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57894-160-01 1 VIAL, SINGLE-USE in 1 BOX contains a VIAL, SINGLE-USE
1 10 mL in 1 VIAL, SINGLE-USE This package is contained within the BOX (57894-160-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103772 10/05/2021
Labeler — Janssen Biotech, Inc. (099091753)
Establishment
Name Address ID/FEI Operations
Janssen Biologics B.V. 409612918 API MANUFACTURE (57894-160), ANALYSIS (57894-160)
Establishment
Name Address ID/FEI Operations
Janssen Biotech, Inc. 038978363 API MANUFACTURE (57894-160), ANALYSIS (57894-160)
Establishment
Name Address ID/FEI Operations
Janssen-Cilag Manufacturing, LLC 963971374 MANUFACTURE (57894-160), ANALYSIS (57894-160)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 MANUFACTURE (57894-160), ANALYSIS (57894-160)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 MANUFACTURE (57894-160), ANALYSIS (57894-160), PACK (57894-160)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc. 053217022 PACK (57894-160)
Establishment
Name Address ID/FEI Operations
Janssen Ortho LLC 084894661 ANALYSIS (57894-160)
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A. 338336589 MANUFACTURE (57894-160)

Revised: 10/2021 Janssen Biotech, Inc.

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