Insulin Glargine U-300 Injection, Solution
Product Images NDC 0955-3900

Product Visual Gallery

This gallery contains 51 technical images submitted to the FDA as part of the official labeling for Insulin Glargine U-300 (NDC 0955-3900). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sanofi-aventis U.s. 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 (99ea856d 9562 443a 9422 1006a3cff2f4 01)

A line graph depicting the Glucose Infusion Rate (GIR) in mg/kg*min over time (hours) after subcutaneous injection of Insulin glargine U-300 at a dose of 0.4 units/kg. The graph shows the GIR measured from 0 to 36 hours post-injection, with a peak around early hours and a gradual decline after about 24 hours.*

FDA Label Image

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An instructional diagram showing recommended subcutaneous injection sites on the human body. The highlighted areas include the upper arms, stomach, and thighs, with labels pointing to each respective site. The illustration is a simplified human figure with these areas marked in green.*

FDA Label Image

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An instructional diagram labeled 'Get to know your pen' showing the components of an Insulin glargine U-300 SoloStar injection pen. Parts identified include the pen cap, cartridge holder, rubber seal, insulin scale, plunger (not visible until used), insulin name and strength label, dose window, dose pointer, dose selector, and injection button.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 04)

Label of an Insulin glargine SoloStar injection pen showing it is for single patient use only, with a strength of 300 units per mL (U-300). The label highlights the proprietary name Insulin Glargine SoloStar and the strength in orange and green text on a white background.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 05)

Pen injector for Insulin glargine U-300 injection solution, showing the lot number and expiration date on the label. The pen is white with green and black dotted designs near the label text area. The label displays lot number 123XY and expiration date 2029-10-31. The device is from Sanofi-Aventis U.S. LLC.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 06)

Illustration showing a hand holding and preparing an insulin pen, specifically the Insulin glargine U-300 injection. The image shows the thumb pressing a button or cap with an arrow indicating the direction of movement, likely demonstrating how to operate or prepare the pen for subcutaneous injection.*

FDA Label Image

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An illustration of a portion of an insulin pen, highlighting the medication reservoir with a white blank label area inside a blue circle. The pen body is light green with design elements, showing the dosing knob and part of the label. This image likely demonstrates the location or feature of the insulin cartridge within a subcutaneous injection pen.*

FDA Label Image

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Illustration showing hands preparing a medication vial for injection by wiping the rubber stopper with an alcohol swab. This instructional image relates to the preparation or administration of an injectable drug solution.*

FDA Label Image

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An instructional illustration depicting two hands preparing a solution injection vial, likely for subcutaneous administration. The visual shows one hand holding the vial while the other hand removes or replaces the cap, related to insulin glargine U-300 (300 units/mL) injection by Sanofi-Aventis U.S. LLC.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 10)

An instructional diagram showing hands removing the protective cap from an Insulin glargine U-300 injectable pen. The cap is twisted off by turning it in the direction indicated by a blue arrow. An inset with a red circle and line warns against pulling the cap straight off, illustrating incorrect removal.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 11)

An instructional illustration showing a hand holding a green insulin glargine U-300 injection pen with a visible dose scale. A second hand is placing the pen cap onto a surface, demonstrating correct handling or preparation of the injection device.*

FDA Label Image

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An instructional illustration showing a hand holding an insulin syringe with measurement markings and another hand placing a small cap or needle cover onto an open vial or container. The image visually depicts a step in the preparation or administration process of an injection solution, likely related to insulin glargine U-300.*

FDA Label Image

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An instructional illustration showing a person adjusting the dose on an insulin glargine U-300 injection pen, highlighting the dose selector on the pen with a close-up of the dose window displaying the numbers 1, 2, and 4.*

FDA Label Image

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Illustration showing proper technique for priming an insulin pen injection device. The image highlights holding the insulin pen upright, pressing the injection button to release insulin through the needle, indicated by a drop of liquid at the needle tip, emphasizing preparing the pen for subcutaneous injection.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 15)

Insulin glargine U-300 injection, solution in a prefilled pen device. The label shows 300 units/mL concentration, with dosage markings visible on the pen. The product is labeled for single patient use only and manufactured by Sanofi-Aventis U.S. LLC. The pen design includes a dose selector and needle end.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 16)

Illustration showing hands holding an insulin glargine U-300 injection pen, demonstrating the action of turning the dose selector dial to set a 10-unit dose for subcutaneous injection.*

FDA Label Image

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Close-up image of the dosage window on an Insulin glargine U-300 injection pen. The visible measurement indicates a dose setting between 28 and 30 units. The injection pen is designed for subcutaneous use, containing insulin glargine at a concentration of 300 units per mL by Sanofi-Aventis U.S. LLC.*

FDA Label Image

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An illustration showing a close-up of a dial or dose selector, indicating the numbers 28 and 30, likely relating to dose measurement increments for insulin injection devices.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 19)

An instructional illustration showing a hand holding an insulin glargine U-300 injection pen, positioned for subcutaneous injection. The image depicts the pen inserted at an angle into the skin, with an arrow indicating the direction of injection.*

FDA Label Image

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Instructional illustration showing proper technique for holding an insulin glargine U-300 injection pen during subcutaneous administration. The image emphasizes gripping the green dosage dial correctly with the thumb and forefinger without covering the dosage window, as shown in a blue circle with a check mark, and warns against improper gripping that blocks the dosage window, highlighted with a red circle and crossed-out symbol.*

FDA Label Image

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Illustration showing a hand holding an insulin glargine U-300 injection pen against a forearm, with zoomed-in views highlighting the injection dose window and a 5-second timing indicator for dose administration.*

FDA Label Image

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An instructional illustration showing a close-up of hands preparing an insulin pen injection. The syringe window displays dosage marks from 50 to 450 units, depicting the setting of the insulin glargine U-300 dose before injection. An arrow indicates the direction for attaching or removing the pen needle cap.*

FDA Label Image

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Instructional illustration depicting the use of a syringe-style injector for Insulin glargine U-300 injection. The image shows hands twisting the cap off the syringe while pressing the push button end, indicating steps to prepare the device for subcutaneous administration.*

FDA Label Image

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An instructional illustration showing hands removing a protective seal from a vial by peeling off a foil covering, with an arrow indicating the removal direction. This image likely demonstrates the first step in preparing an injection vial, relevant to subcutaneous injection medication such as insulin glargine U-300.*

FDA Label Image

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An instructional illustration showing hands holding an insulin glargine U-300 injection pen and its cap. The diagram indicates removing the pen cap by pulling it off in the direction of a blue arrow. This relates to the preparation or use of the insulin injection device.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 26)

An instructional anatomical diagram showing recommended subcutaneous injection sites on the human body for insulin glargine U-300. Highlighted green areas include the upper arms, stomach, and thighs, indicating where injections can be administered.*

FDA Label Image

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Illustration of an insulin glargine U-300 injection pen showing labeled parts including pen cap, cartridge holder with rubber seal and insulin scale, plunger, dose window and dose pointer, dose selector, injection button, and the insulin label on the cartridge. The diagram notes the plunger becomes visible after several doses.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 28)

Insulin Glargine Max SoloStar injection pen labeled U-300, containing insulin glargine 300 units/mL for subcutaneous use, intended for single patient use. The label includes instructions to adjust dosage by 2 units. Manufactured by Sanofi-Aventis U.S. LLC.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 29)

The image shows a prefilled insulin pen labeled as Insulin glargine U-300 injection, solution for subcutaneous use. The pen is beige with a white cap and has a green patterned security label. Visible lot number is 123XY and expiration date is 2029-10-31. Manufactured by Sanofi-Aventis U.S. LLC.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 30)

An instructional illustration showing hands preparing an insulin glargine U-300 injection pen. The image depicts uncapping the pen by pulling the pen cap off in the direction of a blue arrow, displaying the insulin cartridge inside the pen device.*

FDA Label Image

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Illustration showing a close-up of the needle guard area of an Insulin glargine U-300 injection pen. The pen displays the dosage strength of 300 units/mL and features windows on the guard to view the dose or mechanism inside.*

FDA Label Image

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An instructional illustration showing hands cleaning the threaded tip of an injection pen with a cloth or wipe, demonstrating a step in the preparation or maintenance of an insulin pen device.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 33)

An instructional illustration depicting hands removing the cap from a vial or injection device, demonstrating a preparatory step for subcutaneous injection of insulin glargine U-300 solution.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 34)

An instructional illustration showing the removal of the needle cap from an insulin glargine U-300 injection pen by twisting it off. The image highlights the proper twisting motion with arrows, and includes a warning inset not to pull the needle cap straight off.*

FDA Label Image

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An instructional illustration showing a hand holding a small prefilled injection pen labeled for insulin glargine U-300. Another hand is removing the cap from the needle tip, demonstrating preparation for subcutaneous injection of the insulin solution.*

FDA Label Image

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An instructional illustration showing a hand holding a syringe with a needle poised above an open vial, and another hand removing the vial's cap, indicating preparation steps for an injection solution.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 37)

An instructional illustration showing a hand adjusting the dose on an Insulin glargine U-300 injection pen. The close-up inset highlights the dose window displaying a selection of 4 units, demonstrating how to set the injection dose by turning the dial on the pen.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 38)

Instructional illustration showing two hands holding and preparing a syringe labeled for Insulin glargine U-300 injection. A magnified inset highlights the needle tip with a small spray or droplet, demonstrating proper handling or priming of the syringe before subcutaneous injection. The syringe is marked with measurement lines for dosing.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 39)

Insulin glargine U-300 injection pen labeled as Insulin Glargine Max SoloStar Injection (U-300) for single patient use. The pen is marked with 300 units/mL strength and includes a dosage adjustment feature in increments of 2 units. The label indicates it is designed for subcutaneous injection.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 40)

An instructional illustration showing a hand holding an insulin glargine U-300 injection pen, demonstrating how to turn the dose selector dial by rotating the end cap to adjust the insulin dosage. The pen label indicates 'U-300' strength and subcutaneous injection use.*

FDA Label Image

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A close-up illustration showing the dose selector window of an insulin pen injector. The dial displays dosage numbers, with the current dose set around 60 units, demonstrating how users select their insulin dose.*

FDA Label Image

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Illustration showing a close-up view of the dosage selector window on an insulin glargine U-300 pen injector. The display indicates dose units with numbers incrementing in steps, here showing doses between 56 and 60 units.*

FDA Label Image

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An instructional illustration showing a hand holding an insulin glargine U-300 pen injector for subcutaneous injection. The image depicts the injection technique, with the needle inserted into the skin and an arrow indicating the direction to push the plunger.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 44)

An instructional illustration showing a hand holding an insulin glargine U-300 injection pen and demonstrating how to correctly turn the dose selector dial. The diagram highlights the correct way to align the numbers on the dial to select the dose, with an arrow indicating the direction to turn. A correct alignment is marked with a blue circle, and an incorrect alignment is marked with a red circle and cross.*

FDA Label Image

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Instructional illustration showing a hand holding an insulin glargine U-300 injection pen for subcutaneous use. A close-up highlights pressing the injection button and holding it for 5 seconds after injection to ensure full delivery.*

FDA Label Image

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An instructional diagram showing hands holding an insulin glargine U-300 prefilled pen and a needle cap. The illustration indicates the process of attaching or removing a needle cap from the injection pen, with a blue arrow guiding the motion. This visual is related to the use of insulin glargine U-300 injection for subcutaneous administration.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 47)

Illustration showing how to use an insulin syringe or pen device. It depicts a user holding the device with one hand, pressing down on the plunger with a finger of the other hand, and an arrow indicating a twisting or turning movement of the barrel or dial. The image demonstrates proper handling technique for measuring or injecting the insulin solution.*

FDA Label Image

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An instructional illustration showing two hands: one removing a protective cap from a container, and the other holding a small vial or insert with an arrow indicating the vial being placed into the container opening. This likely demonstrates a step for preparing the injection solution.*

FDA Label Image

Image (99ea856d 9562 443a 9422 1006a3cff2f4 49)

Illustration showing hands holding and assembling a prefilled insulin glargine U-300 injection pen by attaching the protective cap. The label on the cartridge indicates insulin glargine 300 units per milliliter concentration.*

FDA Label Image

Principal Display Panel (1.5 mL Pen Carton)

Insulin glargine U-300 SoloStar injection carton label shows 300 units/mL (U-300) solution for subcutaneous injection. The label includes usage instructions, storage information, and safety warnings. It indicates three 1.5 mL prefilled pens per carton and is labeled for single patient use only. Manufactured by Sanofi-Aventis U.S. LLC.*

FDA Label Image

Principal Display Panel (3 mL Pen Carton)

Packaging label for Insulin Glargine Max SoloStar injection U-300 (300 units/mL), a subcutaneous injection solution for single patient use. The carton includes dosing instructions, storage information, and safety warnings. It indicates the product contains two 3 mL prefilled pens and is manufactured by Sanofi-Aventis U.S. LLC. The label highlights the adjustable dose increments of 2 units and specifies the solution is clear and colorless with no visible particles.*

* 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.