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)

This is a description of the titration process for ABSTRAL, a medication used for pain relief. The initial dose is 100mg and if adequate pain relief is achieved within 30 minutes, subsequent doses are increased incrementally for breakthrough pain. Doses should be separated by at least 2 hours. The text also includes information on dosing for different strength tablets, up to a maximum of 500mg.*

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Structural Formula (Abs02 0001 02)

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Figure 1 (Abs02 0001 03)

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Figure 2 (Abs02 0001 04)

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Figures 1 And 2 (Abs02 0001 05)

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Figures 3 And 4 (Abs02 0001 06)

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

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

ABSTRAL® is a brand of sublingual tablets containing fentanyl, an opioid used for severe pain relief. It comes in a pack of 32 sublingual tablets, and each tablet is not meant to be chewed or swallowed. ABSTRAL® comes with an application guide enclosed, for sublingual administration only. The manufacturer, Pharmaceutics International, is located in Hunt Valley, MD, and the product is distributed by Galena Bopharma, in Lake Oswego, OR. Access to ABSTRAL® is restricted to patients with a prescription, and a TIRF REM access program is applicable. For more information, call 1-883-ABSTRAL.*

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

ABSTRAL®C is a medication for sublingual administration that comes in the form of fentanyl sublingual tablets. It includes important safety information that can be found in the enclosed medication guide. Patients should not chew or swallow the tablet whole. The drug should be given to patients for whom it is prescribed. Questions about the product can be addressed by calling 1-863-ABSTRAL.*

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

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

ABSTRAL®G is a sublingual tablet containing fentanyl used for pain management. The package contains 32 sublingual tablets, and each tablet should not be chewed or swallowed whole. There are important safety instructions enclosed in the ABSTRAL® medication guide to be followed while using it. The medication is distributed through a TIRF REMS access program. For queries or questions about ABSTRAL®, call 1-888 ABSTRAL.*

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

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

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.