AVSOLA (Page 13 of 13)

PRINCIPAL DISPLAY PANEL — 100 mg Vial Carton Label

100
mg/vial

AMGEN®

NDC 55513-670-01

AVSOLA®
(infliximab-axxq)
For Injection

100 mg/vial

For Intravenous infusion only

Single-Dose Vial. Discard unused portion.

Contents: Each carton contains one 100 mg AVSOLA Single-Dose Vial.
ATTENTION: Dispense the enclosed Medication Guide to each patient
Reconstitute and Dilute before Intravenous Infusion. Infuse over at least 2 hours with an in-line filter.
Protect from light. Dosage: See Prescribing Information.

Rx Only

PRINCIPAL DISPLAY PANEL -- 100 mg Vial Carton Label
(click image for full-size original)
AVSOLA infliximab-axxq injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-670
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
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 4.9 mg in 10 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 2.2 mg in 10 mL
POLYSORBATE 80 0.5 mg in 10 mL
SUCROSE 500 mg in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-670-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55513-670-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761086 12/12/2019
Labeler — Amgen Inc (039976196)
Establishment
Name Address ID/FEI Operations
BioReliance Corporation 147227730 ANALYSIS (55513-670)

Revised: 04/2023 Amgen Inc

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