Buprenorphine Transdermal System Patch, Extended Release
Product Images NDC 47781-406

24 FDA label images from Alvogen Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Buprenorphine Transdermal System (NDC 47781-406). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alvogen 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

10 Mcg Per Hour Carton (Carton 10mcg Hr)

10 Mcg Per Hour Carton (Carton 10mcg Hr)
Packaging label for Buprenorphine Transdermal System 10 mcg/hour patch by Alvogen Inc. The label indicates it contains 4 extended-release transdermal patches with systemic delivery of 10 mcg per hour for seven days. It also includes instructions for use, storage, and a table for recording application dates. The packaging is yellow with purple highlights and includes a section for affixing a pharmacy label.*
FDA Label Image

15 Mcg Per Hour Carton (Carton 15mcg Hr)

15 Mcg Per Hour Carton (Carton 15mcg Hr)
Packaging label for Buprenorphine Transdermal System 15 mcg/hour patch manufactured by Alvogen Inc. The carton contains 4 transdermal systems and one package of 4 disposal units. The label highlights that this product is for use in opioid-experienced patients only and includes space for pharmacy labeling and dates applied/removed.*
FDA Label Image

20 Mcg Per Hour Carton (Carton 20mcg Hr)

20 Mcg Per Hour Carton (Carton 20mcg Hr)
Packaging label for buprenorphine transdermal system 20 mcg/hour extended-release patch by Alvogen Inc. The carton contains 4 transdermal systems and 4 disposal units, intended for transdermal use. The label includes cautionary text, NDC 47781-408-04, and space for a pharmacy label.*
FDA Label Image

5 Mcg Per Hour Carton (Carton 5mcg Hr)

5 Mcg Per Hour Carton (Carton 5mcg Hr)
Packaging label for Buprenorphine Transdermal System 5 mcg/hour extended release patches by Alvogen Inc. The carton contains 4 transdermal systems (patches) and 4 disposal units. Key information includes the strength (5 mcg/hour), NDC 47781-406-04, and instructions to affix the pharmacy label on the designated area. The label also includes warnings about usage and patient medication guide dispensing.*
FDA Label Image

Figure 1 (Figure 1)

Figure 1 (Figure 1)
An illustration diagram showing the cross-sectional layers of a buprenorphine transdermal system patch. The five labeled layers include: 1. Backing Layer, 2. Overlapping Adhesive Film, 3. Separating Layer, 4. Drug/Polymer Adhesive Matrix, and 5. Peel-off Release Liner.*
FDA Label Image

Figure 2 (Figure 2)

Figure 2 (Figure 2)
A line graph displaying plasma concentration (pg/mL) of buprenorphine over 26 days with a 10 mcg/hour buprenorphine transdermal system applied every 7 days for 3 cycles (N=36). The x-axis represents time in days, and the y-axis shows concentration levels. Concentrations rise and fall with patch application and removal, showing peaks during dosing and decline after removal on day 21.*
FDA Label Image

Figure 3 (Figure 3)

Figure 3 (Figure 3)
A line graph comparing the percentage of patients improved against the percent of reduction or improvement in pain. It displays two curves: one for Placebo and one for Buprenorphine Transdermal System 10/20, showing that a higher percentage of patients improved with the Buprenorphine Transdermal System across increasing levels of pain reduction.*
FDA Label Image

Figure 4 (Figure 4)

Figure 4 (Figure 4)
A line graph showing the percentage of patients improved versus the percent reduction or improvement in pain for Buprenorphine Transdermal System 5 ug/h and 20 ug/h. The graph compares patient improvement rates across varying pain reduction percentages, with two lines representing the 5 ug/h and 20 ug/h strengths of the patch by Alvogen Inc.*
FDA Label Image

Figure A (Figure A)

Figure A (Figure A)
Illustration showing four possible placement sites on the upper body for applying a buprenorphine transdermal system patch. Sites include the upper outer arm, upper chest, upper back, and side of the torso under the arm.*
FDA Label Image

Figure B (Figure B)

Figure B (Figure B)
An illustration showing the placement sites for the buprenorphine transdermal system patches on the upper torso, specifically on the upper back and upper chest areas. The image is labeled as Figure B and depicts two rectangular patches applied on the back of a person.*
FDA Label Image

Figure C (Figure C)

Figure C (Figure C)
An instructional illustration labeled Figure C showing a person with exposed chest demonstrating the application of a transdermal patch using one hand. The image focuses on proper placement on the upper chest area.*
FDA Label Image

Figure D (Figure D)

Figure D (Figure D)
An instructional illustration labeled Figure D showing hands cutting into a pouch or foil packet, demonstrating how to open the packaging of a buprenorphine transdermal system patch.*
FDA Label Image

Figures E-f (Figure E F)

Figures E-f (Figure E F)
An instructional illustration showing the buprenorphine transdermal system patch with labeled components including the patch, foil backing, and foil handle. The image also depicts hands peeling back the foil to remove the patch from its packaging, demonstrating proper handling for application.*
FDA Label Image

Figure G (Figure G)

Figure G (Figure G)
An instructional line drawing showing a person applying a buprenorphine transdermal system patch to the upper chest area. The figure is labeled as 'Figure G' and depicts the proper placement of the medication patch on the skin for transdermal administration.*
FDA Label Image

Figure H (Figure H)

Figure H (Figure H)
An instructional illustration labeled 'Figure H' depicting a person applying a buprenorphine transdermal system patch to the upper chest area. It shows the hands holding and positioning the patch on the skin, demonstrating proper patch application technique.*
FDA Label Image

Figure I (Figure I)

Figure I (Figure I)
An instructional illustration showing the proper application of the buprenorphine transdermal system patch on the upper chest area near the shoulder. The image depicts a person placing the patch onto the skin with one hand.*
FDA Label Image

Figure J (Figure J)

Figure J (Figure J)
An instructional illustration showing two hands opening a packet labeled 'STEP 1' which contains a buprenorphine transdermal patch. The image guides proper handling by peeling back the protective liner to expose the adhesive patch for application.*
FDA Label Image

Figure K (Figure K)

Figure K (Figure K)
An instructional illustration depicting the hands applying a buprenorphine transdermal system patch. One hand is holding the patch while peeling back the backing labeled 'STEP 2,' showing the transdermal patch to be applied on the other hand. This image visually guides the proper method for applying the buprenorphine extended-release transdermal patch.*
FDA Label Image

Figure L (Figure L)

Figure L (Figure L)
An instructional black-and-white line drawing showing a pair of hands holding an open booklet or pamphlet. The visible page contains text titled "STEP 3" with instructions related to the proper handling or application process of a product, including applying pressure and preparing to read further steps.*
FDA Label Image

Figure M (Figure M)

Figure M (Figure M)
An illustration showing a person holding a buprenorphine transdermal system patch, in the process of peeling the protective liner off before application to the skin. The hands are depicted to demonstrate proper handling of the patch.*
FDA Label Image

Figure N (Figure N)

Figure N (Figure N)
An instructional illustration showing a hand holding a square patch above an open trash bin. The image likely depicts proper disposal of a used transdermal patch, such as the buprenorphine transdermal system.*
FDA Label Image

Figure O (Figure O)

Figure O (Figure O)
An instructional line drawing showing a hand disposing of a used patch into a toilet. The illustration likely relates to proper disposal of a transdermal patch, demonstrating dropping the patch into the toilet bowl with the toilet lid open.*
FDA Label Image

Chemical Structure (Structure)

Chemical Structure (Structure)
Chemical structure diagram of buprenorphine, the active ingredient in buprenorphine transdermal system. The structure shows the detailed arrangement of atoms and bonds characteristic of buprenorphine's molecular composition.*
FDA Label Image

Table 1 (Table 1)

Table 1 (Table 1)
A table presenting recommended starting doses for the buprenorphine transdermal system based on previous opioid analgesic daily dose in oral morphine equivalents. It compares doses below 30 mg and between 30 to 80 mg, with corresponding buprenorphine doses of 5 mcg/hour and 10 mcg/hour respectively.*

* 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.