Subsys
Product Images NDC 20482-016

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Subsys (NDC 20482-016). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Insys 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.

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Subsys Titration Process (Subsys 01)

A flowchart illustrating dosing instructions for SUBSYS, starting with a 100 mcg dose. The chart guides the user through consuming one dose, waiting 30 minutes, possibly taking one additional dose, and waiting at least 4 hours before treating another breakthrough pain episode. It then asks if adequate relief is achieved with one dose, directing to either a successful dose determination or increasing to the next highest strength.*

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Fentanyl Chemical Structure (Subsys 02)

Chemical structure diagram of the active ingredient in SUBSYS, showing its molecular configuration with detailed atomic connectivity.*

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Figure 1 (Subsys 03)

A pharmacokinetic graph comparing fentanyl plasma concentrations (ng/mL) over time (hours) between SUBSYS 400 mcg and OTFC 400 mcg. The main graph shows data up to 36 hours, with SUBSYS reaching a higher peak concentration earlier than OTFC. An inset graph depicts fentanyl plasma concentrations over time (minutes) within the first 240 minutes, illustrating the initial rapid absorption phase of both products.*

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Figure 2 (Subsys 04)

A line graph showing fentanyl plasma concentration (ng/mL) over time (hours) for SUBSYS at doses of 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg. Plasma concentrations peak early and decline steadily over a 36-hour period, with higher doses producing higher initial concentrations.*

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Figure 3 (Subsys 05)

A line graph comparing pain intensity difference (PID) over time in minutes for SUBSYS and placebo. The graph shows mean PID with standard error bars from 0 to 60 minutes, with SUBSYS demonstrating a higher pain intensity reduction than placebo across all time points.*

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Figure A (Subsys 06)

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Figure B (Subsys 07)

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Figure C (Subsys 08)

An illustration showing a hand pressing a small, oval-shaped device labeled SUBSYS, which is placed on a surface such as a drawer or table. The image appears to demonstrate how to hold or access the SUBSYS device, a product by Insys Therapeutics, Inc.*

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Figure D (Subsys 09)

Packaging label of SUBSYS spray by Insys Therapeutics, Inc. shows the spray unit with components labeled: nozzle, grip, vial holder, and blister package containing the spray. Also included are disposal instructions with a disposal bag, an aluminum pouch containing disposal pouches, and a labeled disposal pouch with charcoal-lined material for safe disposal of used spray units.*

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Figure E (Subsys 10)

SUBSYS packaging label held by a person using scissors to cut it open. The label shows the proprietary name SUBSYS with text and safety warnings visible, but details are partially obscured by the cutting action. The labeler Insys Therapeutics, Inc. is not visible in the image.*

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Figure F (Subsys 11)

SUBSYS sublingual spray applicator shown being held between two fingers. The device has a white upper part with a circular nozzle and a purple lower part, designed for dispensing medication. The labeler is Insys Therapeutics, Inc.*

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Figure G (Subsys 12)

An illustration showing a person using a SUBSYS single-use transmucosal fentanyl spray device to administer medication into the mouth, demonstrating the proper oral spray technique.*

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Figure H (Subsys 13)

An instructional image showing a person using the SUBSYS nasal spray device. The person holds the white and purple spray applicator close to their nostril, demonstrating proper administration technique for the medication by Insys Therapeutics, Inc.*

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Figure I (Subsys 14)

Illustration showing the proper use of the SUBSYS sublingual spray device. The image depicts a person holding the spray device with a thumb positioned on the bottom and an arrow indicating the direction to press, aiming the nozzle under the tongue for administration.*

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Figure J (Subsys 15)

SUBSYS sublingual spray actuator held between fingers with red nail polish. The device is white with a purple spray tip. No text or dosage information is visible in the image. Labeler shown is Insys Therapeutics, Inc.*

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Figure K (Subsys 16)

An instructional image showing a person holding a SUBSYS disposal bag designed for empty spray units or sealed chlorosal-lined disposal pouches. The bag includes instructions for sealing and use, emphasizing child safety and proper disposal.*

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Figure L (Subsys 17)

The image shows a white disposal bag held by two hands with red nail polish. The bag has printed text providing instructions for disposal, including guidance to seal the bag before placing it in a designated disposal pouch. The product name SUBSYS and labeler Insys Therapeutics, Inc. are not visible on the bag itself.*

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Figure M (Subsys 18)

An instructional image showing a hand with red-painted nails placing a white disposal bag into a trash receptacle. The disposal bag has printed text outlining disposal instructions, emphasizing safe discard of product waste. It is related to the SUBSYS product by Insys Therapeutics, Inc.*

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Figure N (Subsys 19)

An instructional two-panel image showing hands with red-painted nails opening a silver foil pouch. In the first panel, the pouch is being peeled open, and in the second panel, a small folded instruction leaflet is partially removed from the pouch. The image relates to the packaging or use of SUBSYS by Insys Therapeutics, Inc.*

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Figure O (Subsys 20)

An instructional image showing a person's hands using scissors to cut open a sealed blister pack of SUBSYS, a fentanyl sublingual spray. The person has red-painted fingernails and is opening the packaging carefully against a dark background.*

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Figure P (Subsys 21)

The image shows a hand holding a white box with printed text and a small, purple-capped medication applicator or dispenser being lifted from the box. The product is SUBSYS by Insys Therapeutics, Inc. The box and applicator suggest a pharmaceutical product, likely a spray or other form requiring an applicator device.*

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Figure Q (Subsys 22)

Instructional image showing a pair of hands with red painted nails holding and opening a small white foil pouch that contains SUBSYS, a product by Insys Therapeutics, Inc. The pouch has printed text instructions or warnings visible on the front.*

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Figure R (Subsys 23)

An instructional illustration showing a person holding an opened sublingual film pouch labeled SUBSYS. The image depicts how to open and handle the dosing film strip for administration. The pouch has visible printed instructions for use on the inside flap.*

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Figure S (Subsys 24)

A photograph illustrating the proper use of a disposal bag, with a hand holding a small white disposal bag above a trash receptacle. The disposal bag contains printed instructions for use, emphasizing proper disposal of waste.*

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Subsys-25 (Subsys 25)

Packaging label for SUBSYS fentanyl sublingual spray 100 mcg per spray by Insys Therapeutics, Inc. The label indicates dosage form as sublingual spray with active ingredient fentanyl at 100 mcg per spray. It includes warnings about opioid therapy use, safe storage, and administration instructions. The design features blue and white colors with the Insys Therapeutics logo and regulatory information including a barcode and NDC 20482-001-10.*

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Subsys-26 (Subsys 26)

SUBSYS 200 mcg per spray fentanyl sublingual spray packaging label by Insys Therapeutics, Inc. The carton is predominantly green with white text, stating the product name, strength, dosage form, and prescribing information. It includes warnings, storage instructions, and contact information, and mentions that each carton contains 30 device units, each delivering one spray. The label also highlights that the product is Rx only and not substitutable for other fentanyl products.*

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Subsys-27 (Subsys 27)

Packaging label for SUBSYS fentanyl sublingual spray, 400 mcg per spray, by Insys Therapeutics, Inc. The carton is predominantly pink with white text detailing dosage, warnings, manufacturer information, and storage instructions. The label specifies dispensing of an enclosed medication guide and notes the product is for administration under the tongue only, with dosing at least 4 hours apart. The packaging includes a barcode and a statement indicating the product must be supplied through the TIRF REMS Access program.*

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Subsys-28 (Subsys 28)

Packaging label for SUBSYS fentanyl sublingual spray, 600 mcg per spray, by Insys Therapeutics, Inc. The purple and white carton includes dosage instructions, warnings, storage conditions, and barcodes. It indicates dispensing the enclosed medication guide to each patient and states the product is for administration under the tongue only, with dosing at least 4 hours apart.*

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Subsys-29 (Subsys 29)

Packaging label for SUBSYS fentanyl sublingual spray 800 mcg per spray by Insys Therapeutics, Inc. The label is orange with white text and includes usage instructions, warnings, and manufacturer information. The label mentions Rx only and the need to dispense an enclosed Medication Guide with the product.*

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Subsys-30 (Subsys 30)

Packaging label for SUBSYS fentanyl sublingual spray 1200 mcg, supplied as two 600 mcg device units. The label has a brown background with white text, including warnings and usage instructions. The labeler is Insys Therapeutics, Inc. The packaging emphasizes dispensation with an enclosed Medication Guide and notes that SUBSYS should not be substituted for other fentanyl products.*

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Subsys-31 (Subsys 31)

Packaging label for SUBSYS fentanyl sublingual spray 1600 mcg, supplied as two 800 mcg device units. The label is predominantly red with white text and includes warnings, dosage form, and manufacturer Insys Therapeutics, Inc. Directions to dispense the enclosed Medication Guide are also noted.*

* 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.