Firazyr (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 3 mL Syringe Carton — 54092-702-02

Takeda

Prefilled Syringe

Rx ONLY
NDC 54092-702-02

Carton contains:
One single-dose,
prefilled syringe and one 25G
hypodermic needle.
Full prescribing information with
patient injection instructions.
The syringe is closed with a protective cap.

firazyr^®
(icatibant injection)
30 mg/3 mL
(10 mg/mL) FOR SUBCUTANEOUS USE ONLY

PRINCIPAL DISPLAY PANEL — 3 mL Syringe Carton — 54092-702-03

Takeda
Prefilled Syringe

Rx ONLY
NDC 54092-702-03

Carton contains:
Three cartons, each with one single-dose, prefilled syringe
and one 25G hypodermic needle.
Full prescribing information with patient injection instructions.
The syringe is closed with a protective cap.

firazyr^®
(icatibant injection)
30 mg/3 mL(10 mg/mL)

FOR SUBCUTANEOUS USE ONLY

PRINCIPAL DISPLAY PANEL — 3 mL Syringe Carton — 54092-702-01

Takeda

Prefilled Syringe

Rx ONLY
NDC 54092-702-01

Sample — Not For Sale

Carton contains:
One single-dose,
prefilled syringe and one 25G
hypodermic needle.
Full prescribing information with
patient injection instructions.
The syringe is closed with a protective cap.

firazyr^®
(icatibant injection)
30 mg/3 mL
(10 mg/mL) FOR SUBCUTANEOUS USE ONLY

FIRAZYR icatibant acetate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54092-702 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength icatibant acetate (icatibant) icatibant 30.0 mg in 3 mL

Inactive Ingredients Ingredient Name Strength sodium hydroxide 1.95 mg in 3 mL acetic acid 4.03 mg in 3 mL sodium chloride 22.72 mg in 3 mL water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54092-702-02 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS 1 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (54092-702-02) 2 NDC:54092-702-03 3 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS 2 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (54092-702-03) 3 NDC:54092-702-01 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS 3 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (54092-702-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022150 08/25/2011

Labeler — Takeda Pharmaceuticals America, Inc. (830134016)

Revised: 10/2021 Takeda Pharmaceuticals America, Inc.