Nulibry Injection, Powder, Lyophilized, For Solution
Product Images NDC 42358-295

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Nulibry (NDC 42358-295). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sentynl Therapeutics, Inc., 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

Chemical Structure (Nul01 0002 01)

Chemical Structure (Nul01 0002 01)
Chemical structure of fosdenopterin hydrobromide, showing its molecular arrangement including a pterin ring system connected to a phosphorylated sugar moiety, with hydrobromide and dihydrate components indicated.*
FDA Label Image

Figure 1 (Nul01 0002 02)

Figure 1 (Nul01 0002 02)
A survival probability Kaplan-Meier curve comparing NULIBRY/rcPMP treatment versus no treatment over age in months. The solid line represents patients treated with NULIBRY/rcPMP, showing higher survival probability, while the dashed line shows lower survival for untreated patients. Censoring is indicated on both curves.*
FDA Label Image

Figure (Nul01 0002 03)

Figure (Nul01 0002 03)
An instructional illustration depicting two hands manipulating a vial, with arrows indicating a motion likely related to preparing or mixing the lyophilized powder for injection. No text or branding is visible in the image.*
FDA Label Image

Figure (Nul01 0002 04)

Figure (Nul01 0002 04)
An instructional illustration showing components included with Nulibry 9.5 mg intravenous injection powder for solution. Items depicted include a sharps container, vials of sterile water for injection and Nulibry powder, alcohol wipes, syringes, and needles, arranged to aid in preparation and administration.*
FDA Label Image

Figure (Nul01 0002 05)

Figure (Nul01 0002 05)
An instructional line drawing showing a person holding a vial of medication with one hand while using the other hand to remove or handle the vial's cap or stopper. This likely represents the preparation step for using an intravenous lyophilized powder injection.*
FDA Label Image

Figure (Nul01 0002 06)

Figure (Nul01 0002 06)
An instructional illustration showing hands preparing Nulibry injection, powder, lyophilized, for solution. One hand is removing the flip-off cap from a vial, with the vial held by the other hand. Additional vial and components are visible in the background.*
FDA Label Image

Figure (Nul01 0002 07)

Figure (Nul01 0002 07)
An instructional illustration showing hands opening a small sealed pouch or blister pack. The image depicts the action of peeling back the packaging to access the product inside, likely a single-dose container or vial relevant to intravenous injection preparation.*
FDA Label Image

Figure (Nul01 0002 08)

Figure (Nul01 0002 08)
An instructional illustration showing a hand holding a syringe with a vial stopper being twisted and removed. The image demonstrates how to properly open a vial or prepare the syringe before use.*
FDA Label Image

Figure (Nul01 0002 09)

Figure (Nul01 0002 09)
An instructional illustration showing a hand holding a syringe while another hand is pulling the plunger upwards, indicating the drawing of liquid into the syringe. The image depicts a step in preparing an injection for intravenous administration.*
FDA Label Image

Figure (Nul01 0002 10)

Figure (Nul01 0002 10)
Line drawing illustration showing a hand holding a syringe and drawing liquid from a vial. This instructional image demonstrates the preparation of an injection by withdrawing solution into the syringe from a vial, consistent with intravenous drug administration.*
FDA Label Image

Figure (Nul01 0002 11)

Figure (Nul01 0002 11)
An instructional line drawing showing two hands preparing an intravenous injection. One hand holds a syringe drawing liquid from a vial labeled "Sterile Water for Injection, USP." This illustration demonstrates proper vial and syringe handling technique for drug preparation.*
FDA Label Image

Figure (Nul01 0002 12)

Figure (Nul01 0002 12)
An instructional illustration showing a hand holding a vial labeled Nulibry and extracting the powder into a syringe. The syringe plunger is being pulled upwards to draw the solution, indicating preparation of Nulibry injection, powder, lyophilized, for solution for intravenous use.*
FDA Label Image

Figure (Nul01 0002 13)

Figure (Nul01 0002 13)
An instructional diagram showing how to prepare an intravenous injection. It depicts a vial with a highlighted 5 ml mark and an arrow indicating insertion of a syringe into the vial, suggesting the steps for withdrawing or preparing the medication solution.*
FDA Label Image

Figure (Nul01 0002 14)

Figure (Nul01 0002 14)
An instructional illustration showing the preparation of an intravenous injection solution. The image depicts a vial being held above a syringe, with the vial's liquid being drawn into the syringe. There is a magnified inset focusing on the syringe barrel, highlighting volume markings at 1 mL and 2 mL. A hand is shown carefully pulling back the syringe plunger to draw the liquid.*
FDA Label Image

Figure (Nul01 0002 15)

Figure (Nul01 0002 15)
An instructional illustration showing a hand holding a syringe filled with a liquid injection solution. A close-up inset highlights the syringe barrel's measurement markings around the 1 and 2 mL levels. An arrow points upward at the syringe plunger indicating movement. The image demonstrates preparation or withdrawal technique for an intravenous injection.*
FDA Label Image

Figure (Nul01 0002 16)

Figure (Nul01 0002 16)
An instructional illustration showing a hand holding a syringe and vial adapter, demonstrating the connection and measurement process. The close-up highlights the 5 ml mark on the syringe barrel to indicate dosage measurement. The image guides proper preparation or administration technique for an injectable drug solution.*
FDA Label Image

Figure (Nul01 0002 17)

Figure (Nul01 0002 17)
An instructional illustration showing hands preparing an injection by mixing sterile water for injection with a vial labeled Nulibry. The vial contains the lyophilized powder for intravenous administration of fosdenopterin hydrobromide.*
FDA Label Image

Figure (Nul01 0002 18)

Figure (Nul01 0002 18)
An instructional illustration showing a hand holding a vial of medication. The illustration demonstrates the proper technique of rotating or swirling the vial gently, indicated by curved arrows around the vial and hand, likely to mix the lyophilized powder before reconstitution or injection preparation.*
FDA Label Image

Figure (Nul01 0002 19)

Figure (Nul01 0002 19)
An instructional illustration showing two hands engaged in a vial preparation technique, with arrows indicating a hand motion likely used for mixing or reconstituting a lyophilized injection vial solution, relevant for intravenous use.*
FDA Label Image

Figure (Nul01 0002 20)

Figure (Nul01 0002 20)
An instructional line drawing depicting the preparation of Nulibry injection solution. It shows a hand holding a vial labeled 'NULIBRY solution' and another hand holding a syringe, indicating the process of drawing the solution from the vial for intravenous use.*
FDA Label Image

Figure (Nul01 0002 21)

Figure (Nul01 0002 21)
An instructional illustration showing a hand holding a vial and drawing liquid into a syringe, demonstrating preparation of an injection dose. The image focuses on the technique of aspirating medication through the syringe needle, commonly used for intravenous administration.*
FDA Label Image

Figure (Nul01 0002 22)

Figure (Nul01 0002 22)
An instructional illustration showing two hands preparing a syringe. One hand holds a vial labeled 'NULIBRY solution' while the other hand uses a syringe to draw up the solution from the vial, indicating preparation for intravenous injection.*
FDA Label Image

Figure (Nul01 0002 23)

Figure (Nul01 0002 23)
An instructional line drawing showing a hand holding a syringe vial from the top and another hand holding the syringe barrel and plunger. The image depicts the preparation of an injection by drawing solution into the syringe.*
FDA Label Image

Figure (Nul01 0002 24)

Figure (Nul01 0002 24)
An instructional illustration showing a hand holding a syringe to withdraw or inject a liquid into or from a vial or container. The image is likely related to preparing or administering the Nulibry fosdenopterin hydrobromide lyophilized injection for intravenous use.*
FDA Label Image

Figure (Nul01 0002 25)

Figure (Nul01 0002 25)
An instructional line drawing illustrating a hand holding a syringe with a needle attached, showing technique for preparing or administering an injection.*
FDA Label Image

Figure (Nul01 0002 26)

Figure (Nul01 0002 26)
An instructional illustration showing a hand holding a syringe and another hand inserting a vial stopper into the syringe, indicating the preparation of a lyophilized powder injection for solution.*
FDA Label Image

Figure (Nul01 0002 27)

Figure (Nul01 0002 27)
An instructional line drawing demonstrating the preparation of a syringe for injection. It shows a pair of hands, one holding a syringe and the other twisting to remove the plunger, illustrating the initial step in preparing the device for use.*
FDA Label Image

Figure (Nul01 0002 28)

Figure (Nul01 0002 28)
An instructional illustration showing a hand pouring a substance from a small container into a larger, wider-mouthed container. The larger container has a hinged lid that is open, suggesting preparation or mixing of a solution, likely related to the medication Nulibry injection preparation process.*
FDA Label Image

Figure (Nul01 0002 29)

Figure (Nul01 0002 29)
An instructional illustration depicting the preparation of an injection vial. It shows a syringe being filled by drawing liquid from a vial with the cap partially open, likely demonstrating reconstitution or withdrawal of medication for intravenous administration.*
FDA Label Image

Principal Display Panel – 9.5 mg Carton Label (Nul01 0002 30)

Principal Display Panel – 9.5 mg Carton Label (Nul01 0002 30)
Label for Nulibry (fosdenopterin) injection, powder, lyophilized, for solution with strength 9.5 mg per vial. The label includes storage instructions to keep frozen between -25°C and -10°C, preparation directions to reconstitute with 5 mL sterile water, and dosing information reference. Distributed by Sentynl Therapeutics, Inc.*

* 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.