Chemical Structure (Belbuca 01)
Chemical structure diagram of buprenorphine hydrochloride, the active ingredient in BELBUCA buccal film.*
Belbuca Film, Soluble
Product Images NDC 59385-026
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Belbuca (NDC 59385-026). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Biodelivery Sciences International 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.
Product Images & Figures Index
Figure 1 (Belbuca 02)
A line graph comparing the cumulative percentage of patients with response between BELBUCA and placebo groups. The x-axis represents the percentage improvement in pain intensity from titration to week 12, ranging from ≥0% to 100%. The y-axis shows the cumulative percentage of patients with response, from 0% to 100%. Two lines depict higher response rates in the BELBUCA group (solid circles) versus placebo group (open squares) across increasing pain improvement thresholds.*
Figure 2 (Belbuca 03)
A line graph comparing the cumulative percentage of patients with response between BELBUCA and placebo groups. The x-axis represents the percentage improvement in pain intensity from titration to week 12, ranging from 0% to 100%. The y-axis shows the cumulative percentage of patients with response, from 0 to 100%. Two lines are plotted: one for BELBUCA with higher response percentages, and one for placebo with lower response percentages across the improvement spectrum.*
Figure A (Belbuca 04)
Packaging label of BELBUCA buccal film by BioDelivery Sciences International Inc. The label includes usage instructions emphasizing patient guidance, film placement inside the cheek, and storage conditions. The label shown corresponds to a small, square film pouch, featuring printed text, barcodes, and a QR code for reference.*
Figure B (Belbuca 05)
Packaging label for BELBUCA buprenorphine hydrochloride buccal soluble film. The label includes patient instructions for use, such as holding the film with the yellow side facing up, placing it against a moistened cheek, holding for 5 seconds, and avoiding eating or drinking until fully dissolved. Storage instructions and the labeler BioDelivery Sciences International Inc., Raleigh, NC, are also visible.*
Figure C (Belbuca 06)
An instructional image showing hands holding a yellow BELBUCA buccal film and its paper backing with application directions. The backing includes text instructions on how to apply the buccal film inside the cheek, emphasizing proper handling and placement.*
Figure D (Belbuca 07)
A black and white photograph showing a human hand with the index finger raised, holding a small square soluble film on its fingertip. The image visually demonstrates the size and form of a buccal film dosage form, consistent with products like BELBUCA (buprenorphine hydrochloride) soluble films intended for buccal administration.*
Figure E (Belbuca 08)
An illustration showing a person placing a BELBUCA (buprenorphine hydrochloride) soluble film inside the mouth onto the buccal mucosa using a finger, demonstrating the proper administration route for this buccal film dosage form.*
Figure F (Belbuca 09)
Illustration showing a close-up of an open mouth with a soluble buccal film placed on the inner cheek, demonstrating the proper placement of BELBUCA buprenorphine hydrochloride film for administration.*
Principal Display Panel (75 mcg Film Pouch Box)
Packaging label for Belbuca 75 mcg buprenorphine buccal film by BioDelivery Sciences International Inc. The label shows a 60-pouch carton with directions to use the entire buccal film pouch, storage temperature instructions, and warnings to keep out of reach of children. The label also includes dosage guidance, manufacturer information, and barcodes for product identification.*
Principal Display Panel (150 mcg Film Pouch Box)
Packaging label for Belbuca 150 mcg buprenorphine buccal film, a soluble film dosage form for buccal administration. The label indicates a 60 pouch count, each containing one buccal film. It includes storage instructions, usage directions, and manufacturer info for BioDelivery Sciences International Inc. The label has multiple barcodes and the Rx only symbol.*
Principal Display Panel (300 mcg Film Pouch Box)
BELBUCA 300 mcg buprenorphine buccal film packaging label. The label shows the brand name BELBUCA, the generic name buprenorphine buccal film, and strength of 300 mcg. It includes handling instructions for use as a buccal film, storage information, manufacturer BioDelivery Sciences International Inc., Raleigh, NC, and barcodes. The package contains 60 pouches with one buccal film each.*
Principal Display Panel (450 mcg Film Pouch Box)
Packaging label for Belbuca buprenorphine buccal film, 450 mcg strength. The label shows the product name, strength, and form as a soluble buccal film. It includes instructions to use entire film without cutting or chewing, and storage conditions between 20°C to 25°C with permitted excursions. The labeler is BioDelivery Sciences International Inc. The package contains 60 pouches, with one film per pouch.*
Principal Display Panel (600 mcg Film Pouch Box)
Box packaging for Belbuca 600 mcg buprenorphine buccal film by BioDelivery Sciences International Inc. The label shows it contains 60 pouches, each with one buccal film. Instructions for use, storage conditions, and manufacturer details are included along with multiple barcodes. The label emphasizes the strength as 600 mcg and provides warnings against cutting, tearing, chewing, or swallowing the film.*
Principal Display Panel (750 mcg Film Pouch Box)
Packaging label for Belbuca 750 mcg buprenorphine buccal film. The box contains 60 pouches each with 1 buccal film. It includes storage instructions and manufacturer details: BioDelivery Sciences International, Inc. The label emphasizes using the entire film without cutting, tearing, chewing, or swallowing and provides directions for proper administration.*
Principal Display Panel (900 mcg Film Pouch Box)
Packaging label for Belbuca buprenorphine buccal film 900 mcg by BioDelivery Sciences International Inc. The label shows the product name and strength prominently, indicates that the film is soluble and for buccal use, and includes directions for use. It states the package contains 60 pouches with 1 buccal film each. Storage instructions (20°C to 25°C) and manufacturer information appear alongside a barcode and cautionary notes.*
* 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.
