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 -- 54092-702-02
(click image for full-size original)

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 -- 54092-702-03
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 3 mL Syringe Carton -- 54092-702-01
(click image for full-size original)
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.

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