Subsys
Product Images NDC 71500-004

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Subsys (NDC 71500-004). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by West Therapeutics Development, 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.

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Subsys Titration Process (Subsys 01)

An instructional flowchart outlining dosing guidance for SUBSYS, starting with a 100 mcg dose. The steps include consuming one dose, waiting 30 minutes, possibly consuming one additional dose if needed, limiting to no more than two doses per breakthrough pain episode, and waiting at least 4 hours before another episode treatment. The flowchart directs to determine if adequate relief is achieved with one dose, leading to either 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, likely representing fentanyl or an analog, associated with the product SUBSYS by West Therapeutics Development, LLC. The diagram displays the molecular framework with aromatic rings and functional groups linked by bonds.*

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Figure 1 (Subsys 03)

A line graph showing fentanyl plasma concentration (ng/mL) over time (hours) comparing SUBSYS 400 mcg and OTFC 400 mcg. It includes an inset graph showing plasma concentration over time in minutes, highlighting earlier concentration changes. Both show concentration peaks and declines over the measured period.*

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Figure 2 (Subsys 04)

A line graph depicting fentanyl plasma concentration (ng/mL) over time (hours) for SUBSYS at varying doses of 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg. The graph shows concentration declining over 36 hours, with initial peak levels proportional to dose.*

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Figure 3 (Subsys 05)

A line graph comparing the mean pain intensity difference (PID) over time (up to 60 minutes) between SUBSYS and placebo groups. The x-axis shows time in minutes, and the y-axis shows PID values with error bars indicating standard error measurements.*

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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 instructional black and white line drawing showing a hand retrieving a SUBSYS unit from a drawer. The image demonstrates handling or storage of the SUBSYS product by West Therapeutics Development, LLC.*

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Figure D (Subsys 09)

An illustrated diagram showing the components of the SUBSYS fentanyl sublingual spray packaging by West Therapeutics Development, LLC. Labeled parts include the blister package with nozzle, grip, and vial holder; a disposal bag with usage instructions; an aluminum pouch containing disposal pouches; and the disposal pouch itself with charcoal-lined instructions for proper disposal of used spray units.*

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Figure E (Subsys 10)

Packaging label of SUBSYS by West Therapeutics Development, LLC being opened with scissors by a person with red-painted nails. The label is primarily white with blue text and features warnings and directions visible but not fully legible in the image.*

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Figure F (Subsys 11)

SUBSYS fentanyl sublingual spray device held in hand against a dark background, showing the white nasal spray nozzle and purple base. The device is designed for sublingual delivery of fentanyl, produced by West Therapeutics Development, LLC.*

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Figure G (Subsys 12)

An instructional image showing a person placing the SUBSYS sublingual spray under their tongue. The image demonstrates correct administration technique for this dosage form of SUBSYS by West Therapeutics Development, LLC.*

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Figure H (Subsys 13)

An illustration depicting the administration of a sublingual spray, showing a person holding the white and purple spray device near their open mouth, preparing to use it. No specific product branding or text is visible on the device itself.*

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Figure I (Subsys 14)

An instructional image showing a person administering a dose of SUBSYS using its sublingual spray device. The person holds the device with one hand, positioning the nozzle under the tongue, with red arrows indicating the direction to press and spray for proper use.*

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Figure J (Subsys 15)

SUBSYS is shown as a small, single-dose purple sublingual spray unit held between fingers with red nail polish. The device has a white plastic actuator with a circular button on top for delivery. The image displays the unit's compact, portable design by West Therapeutics Development, LLC.*

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Figure K (Subsys 16)

An instructional image showing hands holding a SUBSYS disposal bag with printed directions for safely sealing and disposing of an empty spray unit or sealed chlorosal-lined disposal pouch. The image highlights the proper closure of the disposal bag and safety warnings.*

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Figure L (Subsys 17)

A white disposal bag held by two hands with red-painted nails. The bag has printed text providing instructions: use for disposal of used fentanyl transdermal patches, keeping the pouch sealed until placing it in the trash, and avoiding ingestion of contents. The label includes the product name SUBSYS by West Therapeutics Development, LLC.*

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Figure M (Subsys 18)

An instructional image showing a hand disposing of a white SUBSYS disposal bag into a trash bin. The disposal bag has printed text with instructions for safely discarding a used SUBSYS unit, emphasizing safe handling and disposal.*

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Figure N (Subsys 19)

A two-panel instructional image showing hands opening a silver foil pouch and removing a folded paper card. The product is SUBSYS by West Therapeutics Development, LLC, but the image focuses on the packaging and opening process, without displaying specific dosage or drug details.*

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Figure O (Subsys 20)

The image shows hands using scissors to open a foil pouch of SUBSYS, a prescription medication by West Therapeutics Development, LLC. The packaging is primarily white with blue and red text, containing product information and warnings. The foil pouch appears to be individually sealed for single-dose use.*

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Figure P (Subsys 21)

An instructional image showing hands holding a SUBSYS unit, a fentanyl sublingual spray. The left hand stabilizes the product while the right hand presses the spray actuator, demonstrating its proper use. The background is dark, highlighting the white and blue medication device.*

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Figure Q (Subsys 22)

The image shows a person holding a small white foil packet for SUBSYS, a product by West Therapeutics Development, LLC. The packet has a printed label with black text, but the text content is not fully legible in the image. The packet appears to be a single-dose unit.*

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Figure R (Subsys 23)

An instructional image showing a person's hands holding an open disposal bag with a small foil unit inside. The disposable bag has printed step-by-step instructions for safely disposing of the foil unit, emphasizing careful handling to prevent environmental contamination.*

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Figure S (Subsys 24)

An instructional image showing a hand with red nail polish disposing a labeled SUBSYS disposal bag into a trash bin. The disposal bag label includes instructions for safe disposal of SUBSYS fentanyl sublingual tablets, emphasizing avoiding accidental exposure, proper sealing, and disposal in household trash.*

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71500-001-10 (Subsys 25 2)

Packaging label for SUBSYS fentanyl sublingual spray 100 mcg per spray by West Therapeutics Development, LLC. The label includes warnings about safety and proper use, directions to dispense the enclosed Medication Guide, and storage instructions. The design is primarily blue and white with the product name and strength prominently displayed.*

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Ndc 71500-002-30 (Subsys 26 2)

Packaging label for SUBSYS fentanyl sublingual spray 200 mcg per spray by West Therapeutics Development, LLC. The label includes dosage strength, administration instructions, warnings, and manufacturer information with a primarily green and white color scheme.*

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71500-004-30 (Subsys 27 2)

SUBSYS fentanyl sublingual spray 400 mcg per spray carton from West Therapeutics Development, LLC. The packaging includes dosage information, warnings, and manufacturer details. The label indicates it is for prescription use only and includes a barcode and lot number area. The design features a predominantly magenta color with white text and security patterns.*

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71500-006-30 (Subsys 28 2)

SUBSYS fentanyl sublingual spray 600 mcg per spray packaging label. The box is primarily purple with white text describing the product name, active ingredient, strength, dosage form, and usage instructions. Labeler is West Therapeutics Development, LLC. Warnings and storage instructions are also included. The label indicates that it is for prescription use only (Rx only).*

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71500-008-30 (Subsys 29 2)

Flat layout of the SUBSYS fentanyl sublingual spray carton in 800 mcg per spray strength. The box is primarily orange with white text and includes dosage instructions, manufacturer info for West Therapeutics Development, LLC, and a barcode. It specifies the product as prescription only with safety warnings and patient information references.*

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71500-012-15 (Subsys 30 2)

Packaging label for SUBSYS fentanyl sublingual spray 1200 mcg, supplied as two 600 mcg device units. The label instructs to dispense the enclosed Medication Guide to each patient and highlights warnings about proper use and substitution safety. The label displays the labeler as West Therapeutics Development, LLC and includes standard pharmacy dispensing information such as 'Rx Only' and storage precautions.*

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71500-016-15 (Subsys 31 2)

Packaging label for SUBSYS 1600 mcg fentanyl sublingual spray by West Therapeutics Development, LLC. The box includes branding, dosage strength, administration form, and warnings, stating the product consists of two 800 mcg device units. The label includes directions to dispense the medication guide with the product and highlights that SUBSYS should not be substituted for other fentanyl products.*

* 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.