Icatibant Injection, Solution
Product Images NDC 63323-574

Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Icatibant (NDC 63323-574). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Ica00 0002 01)

Chemical structure of the active ingredient Icatibant, shown as a complex molecular diagram with multiple rings, side chains, and functional groups characteristic of its peptide nature.*

FDA Label Image

Figure 2 (Ica00 0002 02)

A survival curve chart comparing the proportion of patients not achieving a 50% reduction in symptoms over time (hours) after dosing with Firazyr (Icatibant) versus placebo. The solid line represents Firazyr (N=43) and the dashed line represents placebo (N=45), showing faster symptom reduction in the Firazyr group.*

FDA Label Image

Fresenius Kabi Logo (Ica00 0002 03)

Icatibant 10 mg/mL injection, solution, for subcutaneous use, in a 3 mL single-dose vial. The label prominently displays the product name and strength, along with the labeler name Fresenius Kabi USA, LLC. Additional vial information and regulatory details are partially visible on the white label.*

FDA Label Image

Figure A (Ica00 0002 04)

An instructional diagram showing components of an Icatibant injection kit: a prefilled syringe labeled with plunger, syringe barrel, and protective cap over syringe tip; a capped needle with needle cap seal, needle, and needle cap; and an alcohol wipe packet (not included in carton).*

FDA Label Image

Figure B (Ica00 0002 05)

An instructional illustration showing how to open a rectangular box and reveal the contents inside. The sequence depicts a hand tearing a perforated strip to open the box, then sliding out an inner container, and finally exposing a prefilled syringe and needle assembly inside the packaging.*

FDA Label Image

Figure C (Ica00 0002 06)

An instructional line drawing depicting a pair of gloved hands preparing an injection. One hand is holding the injection vial or syringe, while the other hand grasps the protective cap or device, illustrating a step in medication administration preparation.*

FDA Label Image

Figure D (Ica00 0002 07)

An instructional diagram showing two hands. The left hand holds a syringe with the cap removed, while the right hand holds the syringe cap, positioned to be placed onto or removed from the syringe tip. The image illustrates proper handling of a syringe for subcutaneous injection preparation, relevant to Icatibant injection solution, 10 mg/mL by Fresenius Kabi USA.*

FDA Label Image

Figure E (Ica00 0002 08)

An instructional line drawing showing two hands preparing a syringe by attaching or removing a protective cover or needle cap prior to subcutaneous injection. The image demonstrates proper handling technique for the injection device.*

FDA Label Image

Figure F (Ica00 0002 09)

An instructional illustration showing the front torso with two dashed rectangular areas indicated on the lower abdomen. The diagram likely demonstrates recommended subcutaneous injection sites for Icatibant injection, solution, 10 mg/mL.*

FDA Label Image

Figure G (Ica00 0002 10)

An instructional illustration showing a hand holding a cloth or wipe and cleaning an area of skin, likely preparing the site for a subcutaneous injection.*

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Figure H (Ica00 0002 11)

An instructional illustration showing hands preparing a syringe, with one hand holding the syringe and the other pulling the protective cap off the needle before injection.*

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Figure I (Ica00 0002 12)

An illustration depicting a hand holding a syringe, positioned for a subcutaneous injection. The syringe is shown with a plunger and needle, demonstrating proper grip technique for administration. No product labeling or text is visible in the image.*

FDA Label Image

Figure J (Ica00 0002 13)

An instructional line drawing illustrating the administration of a subcutaneous injection into the abdominal area. The image depicts a hand holding a syringe angled towards the skin near the navel, demonstrating the correct injection technique.*

FDA Label Image

Figure K (Ica00 0002 14)

An instructional illustration depicting subcutaneous injection techniques for Icatibant injection, solution. It shows hand positioning and syringe angles at 45 degrees and 90 degrees relative to the skin surface, indicating appropriate angles for administration.*

FDA Label Image

Figure L (Ica00 0002 15)

An instructional illustration showing a hand preparing a syringe for subcutaneous injection into the abdomen. The image depicts the hand holding the syringe with an arrow indicating the direction for inserting or injecting beneath the skin.*

FDA Label Image

Figure M (Ica00 0002 16)

An instructional diagram showing a hand holding a syringe poised to inject medication subcutaneously into the skin of a person's upper arm or thigh area. The image demonstrates the proper technique for administering an injection beneath the skin surface.*

FDA Label Image

Figure N (Ica00 0002 17)

Illustration showing a hand holding a syringe approaching the skin of the lower abdomen, indicating the subcutaneous injection site. The image is instructional, depicting how to properly administer an injection into the subcutaneous tissue.*

FDA Label Image

Figure O (Ica00 0002 18)

An instructional illustration showing a hand wearing a glove inserting a syringe into the opening of a biohazard sharps disposal container. The image depicts proper disposal of used needles.*

FDA Label Image

Fresenius Kabi Logo (Ica00 0002 19)

Icatibant 10 mg/mL injection, solution in a 3 mL vial labeled for subcutaneous use. The vial label shows the proprietary name Icatibant, strength 10 mg/mL, and the labeler Fresenius Kabi USA, LLC. The image includes two vials, clearly depicting the product's packaging and labeling details.*

FDA Label Image

Package Label (PRINCIPAL DISPLAY – Icatibant Injection 3 mL Syringe Label)

Label for Icatibant Injection, strength 30 mg per 3 mL (10 mg per mL), indicated for subcutaneous use only. The label includes the proprietary name Icatibant, the dosage strength, the Rx only designation, and the manufacturer Fresenius Kabi, made in Austria. Two barcodes and partial lot and expiration date fields are also visible.*

FDA Label Image

Package Label (PRINCIPAL DISPLAY – Icatibant Injection 3 mL Carton Panel Label)

Packaging label for Icatibant Injection, 30 mg per 3 mL (10 mg per mL) solution for subcutaneous injection. The box indicates one 3 mL prefilled syringe, preservative-free, for single use, labeled by Fresenius Kabi USA, LLC. The label includes storage instructions, inactive ingredients, and states the product is made in Austria.*

FDA Label Image

Package Label (PRINCIPAL DISPLAY – Icatibant Injection 3 mL Syringe Label)

Label for Icatibant Injection, showing a concentration of 30 mg per 3 mL (10 mg per mL) for subcutaneous use. The label includes the Rx only designation and is marked as made by Fresenius Kabi USA, LLC, with product NDC 63323-574-01. Barcodes are also visible on the label.*

FDA Label Image

Package Label (PRINCIPAL DISPLAY – Icatibant Injection 3 mL Carton Panel Label)

Packaging label for Icatibant Injection, 10 mg/mL (30 mg per 3 mL) solution for subcutaneous use. The label shows the product is preservative-free, supplied as a single 3 mL prefilled syringe. The labeler is Fresenius Kabi USA, LLC. The carton includes usage instructions and storage conditions, along with barcodes and manufacturer information indicating the product is made in Austria.*

FDA Label Image

Package Label (PRINCIPAL DISPLAY – Icatibant Injection 3 mL Carton Panel Label)

Packaging label for Icatibant Injection, 30 mg per 3 mL (10 mg per mL), solution for subcutaneous injection. The label states it's preservative free and contains 3 x 3 mL prefilled syringes. The labeler is Fresenius Kabi USA, LLC, and the product is prescription only.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.