Abstral
Product Images NDC 57881-331

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Abstral (NDC 57881-331). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Galena Biopharma, 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

Figure (Abs02 0001 01)

A flowchart illustrating the Abstral titration process for breakthrough pain. It starts with an initial dose of 100 mcg and asks if adequate pain relief is achieved within 30 minutes. If yes, the dose is used for subsequent episodes; if no, a supplemental dose is taken, and the dose is increased incrementally based on a provided table. The table details Abstral doses from 200 mcg to 800 mcg with corresponding tablet counts and combinations. It notes doses should be separated by at least 2 hours.*

FDA Label Image

Structural Formula (Abs02 0001 02)

Chemical structure of the active ingredient in Abstral by Galena Biopharma, Inc., shown as a two-part molecular diagram with structural formulae displaying connected atoms and functional groups.*

FDA Label Image

Figure 1 (Abs02 0001 03)

A pharmacokinetic line graph showing fentanyl plasma concentration (ng/mL) over time (hours) for Abstral at doses of 100 mcg, 200 mcg, 400 mcg, and 800 mcg. The graph includes error bars indicating variability around the mean values for each dose group.*

FDA Label Image

Figure 2 (Abs02 0001 04)

A line graph comparing mean pain intensity difference over time (up to 60 minutes) between Abstral and placebo. The x-axis represents time in minutes, and the y-axis represents mean pain intensity difference. Data points with error bars show that pain intensity reduction increases over time for both groups, with Abstral showing a consistently greater effect than placebo throughout the period.*

FDA Label Image

Figures 1 And 2 (Abs02 0001 05)

Instructional illustration showing hands peeling apart a two-layer backing to reveal a transdermal patch. The first frame demonstrates pulling the top layer backward to separate it from the patch, and the second frame shows fully removing the top layer, exposing the adhesive surface of the patch for application.*

FDA Label Image

Figures 3 And 4 (Abs02 0001 06)

Instructional illustrations from Abstral by Galena Biopharma, Inc. showing how to open the protective pouch containing the product. The left illustration (Figure 3) depicts a hand pulling the pouch open, and the right illustration (Figure 4) shows peeling off a layer from the packaging to access the product inside.*

FDA Label Image

Figures 5, 6, And 7 (Abs02 0001 07)

Illustration diagrams showing the steps for using a sublingual tablet or film. Figure 5 depicts a hand placing the medication under the tongue, Figure 6 shows the tablet or film positioned on the sublingual area, and Figure 7 shows the mouth open with the tongue raised, illustrating proper placement for absorption.*

FDA Label Image

Principal Display Panel – 100 Mcg Carton Label (Abs02 0001 08)

Packaging label for Abstral sublingual tablets containing 100 mcg fentanyl base, manufactured for Galena Biopharma, Inc. The label shows 32 sublingual tablets (4 tablets x 8 cards) with warnings for use only in patients tolerant to around-the-clock opioid therapy. It includes instructions for sublingual administration and the Galena Biopharma logo.*

FDA Label Image

Principal Display Panel – 200 Mcg Carton Label (Abs02 0001 09)

Abstral 200 mcg (fentanyl) sublingual tablets packaging label by Galena Biopharma, Inc. The label states the product contains 32 sublingual tablets (4 tablets x 8 cards) for sublingual administration. It includes warnings to keep out of reach of children and cautions about opioid therapy, with instructions not to chew or swallow the tablet whole. The label shows the NDC 57881-332-32 and the manufacturer information.*

FDA Label Image

Principal Display Panel – 300 Mcg Carton Label (Abs02 0001 10)

Packaging label for Abstral (fentanyl) sublingual tablets equivalent to 300 mcg fentanyl base. The label indicates a package size of 32 sublingual tablets (4 tablets x 8 cards) and highlights important warnings, including use only by patients tolerant to opioid therapy, and instructions for sublingual administration without chewing or swallowing whole. The labeler is Galena Biopharma, Inc., and manufacturing information for Pharmaceutics International, Inc. is included.*

FDA Label Image

Principal Display Panel – 400 Mcg Carton Label (Abs02 0001 11)

Packaging label for Abstral 400 mcg (fentanyl) sublingual tablets. The box contains 32 sublingual tablets, arranged as 4 tablets per card and 8 cards total. Manufactured by Pharmaceutics International, Inc. for Galena Biopharma, Inc. The label includes warnings about restricted use, instructions for sublingual administration, and contact information for questions about Abstral.*

FDA Label Image

Principal Display Panel – 600 Mcg Carton Label (Abs02 0001 12)

The packaging label for Abstral (fentanyl) sublingual tablets, equivalent to 600 mcg fentanyl base. The box contains 32 sublingual tablets (4 tablets x 8 cards). Manufactured by Pharmaceutics International, Inc. and labeled for Galena Biopharma, Inc. The label includes warnings to keep out of reach of children and instructions for sublingual administration without chewing or swallowing whole.*

FDA Label Image

Principal Display Panel – 800 Mcg Carton Label (Abs02 0001 13)

Packaging label for Abstral sublingual tablets containing 800 mcg of fentanyl base. The package contains 32 sublingual tablets (4 tablets per card, 8 cards total). Labeler is Galena Biopharma, Inc. The label includes warnings about opioid use, instructions for sublingual administration, and contact information for product questions.*

* 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.