Austedo Xr Tablet, Film Coated, Extended Release
Product Images NDC 68546-472

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Austedo Xr (NDC 68546-472). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Teva Neuroscience, 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

Chemical-structure.jpg (Image 1)

Chemical structure diagrams of RR-Deutetrabenazine and SS-Deutetrabenazine, the active ingredient in AUSTEDO, showing their molecular conformations with labeled D3CO groups.*

FDA Label Image

Figure-01.jpg (Image 2)

A line graph comparing the mean (SEM) Total Maximal Chorea Score over a 13-week study period between AUSTEDO and placebo groups. The graph includes markers for dose titration and a washout phase around week 12, with AUSTEDO showing a decrease in scores compared to placebo. Sample sizes for each group at various study weeks are displayed below the x-axis.*

FDA Label Image

Figure-02.jpg (Image 3)

A bar graph comparing the percent of patients showing improvement or worsening in Total Chorea Score from baseline to maintenance between AUSTEDO and placebo groups. The x-axis shows score changes in ranges from greater than -12 to over 8, with arrows indicating improvement to the left and worsening to the right. The y-axis shows the percent of patients. The graph includes black bars for AUSTEDO and white bars for placebo, illustrating distribution of patient response rates.*

FDA Label Image

Figure-03.jpg (Image 4)

A line graph depicting the mean (SE) change over 12 study weeks in patients treated with AUSTEDO at 12 mg/day, 24 mg/day, 36 mg/day, and placebo. The y-axis shows the mean (SE) values, and the x-axis marks study weeks (0 to 12). The graph includes a patient count table for each treatment group at various time points.*

FDA Label Image

Figure-04.jpg (Image 5)

A bar chart showing the percent of patients by magnitude of improvement from baseline in AIMS total score for placebo and AUSTEDO 12 mg, 24 mg, and 36 mg doses. The x-axis categorizes improvement levels; the y-axis shows the percent of patients. Data compare placebo to three different AUSTEDO dose groups.*

FDA Label Image

Image (Image 6)

AUSTEDO 6 mg tablets carton label showing 60 tablets. The active ingredient is deutetrabenazine. The label includes storage instructions (store at 25°C, protect from light and moisture), dosage form as tablets, and the labeler as Teva Neuroscience, Inc. There is a barcode and a lot/expiration area on the right side.*

FDA Label Image

Image (Image 7)

Austedo 9 mg tablets bottle label from Teva Neuroscience, Inc. The label states each tablet contains 9 mg of deutetrabenazine. The bottle contains 60 tablets. Storage instructions and medication guide requirements are included, along with the Teva logo and distributor information.*

FDA Label Image

Image (Image 8)

Austedo 12 mg tablets packaging label by Teva Neuroscience, Inc. The label states each tablet contains 12 mg deutetrabenazine with a total of 60 tablets in the container. Directions advise swallowing the tablet whole without chewing, crushing, or breaking. Additional storage and safety information, barcode, NDC number 68546-172-60, and distributor address are visible.*

FDA Label Image

Image (Image 9)

AUSTEDO Patient Titration Kit packaging label showing 12 mg starting dose tablets. The label includes multiple strengths of deutetrabenazine tablets (6 mg to 48 mg) and is marked as a 4-week kit. The labeler is Teva Neuroscience, Inc. The label features barcode and QR code, dosage instructions for weeks 1 to 4, and states 'Rx Only.' The design uses purple, white, green, and blue colors.*

FDA Label Image

Image (Image 10)

Packaging label for Austedo tablets 6 mg, 9 mg, and 12 mg by Teva Neuroscience, Inc. This 4-week patient titration kit is for chorea associated with Huntington's disease and includes a monthly carton with 40 tablets in child-resistant packs. The label features dosing instructions, medication guide requirement, storage conditions, contact information, a barcode, and a QR code for patient support.*

FDA Label Image

Image (Image 11)

Austedo (deutetrabenazine) tablets Tardive Dyskinesia Titration Pack 12 mg Starting Dose, containing 6 mg and 9 mg tablets. The packaging label includes dosage information, medication guide requirement, storage instructions, and is labeled as sample not for sale. The labeler is Teva Neuroscience, Inc., with an NDC of 68546-176-28. The design features purple and white colors with a distinctive layout for titration dosing.*

FDA Label Image

Image (Image 12)

AUSTEDO 6 mg tablets carton label by Teva Neuroscience, Inc., marked as a "Titration Pack" for chorea associated with Huntington's disease. The label includes instructions for use, dosage form, and sample indication, prominently stating "SAMPLE - NOT FOR SALE." It features storage instructions, barcode, and the Teva logo.*

FDA Label Image

Image (Image 13)

Label for AUSTEDO XR 48 mg extended-release tablets by Teva Neuroscience, Inc. The label states the active ingredient deutetrabenazine, with a package count of 30 tablets. It includes storage instructions, dispensing requirements, and a barcode.*

FDA Label Image

Image (Image 14)

Packaging label for Austedo XR (deutetrabenazine) extended-release tablets by Teva Neuroscience, Inc. This is a once-daily patient titration kit for 4 weeks, including 6 mg, 12 mg, and 24 mg strengths. The monthly carton contains 42 tablets in child-resistant packs with various tablet colors and doses. The label includes medication guide instructions and the NDC 68546-490-52.*

FDA Label Image

Image (Image 15)

Packaging label for Austedo XR (deutetrabenazine) extended-release tablets in strengths 12 mg, 18 mg, 24 mg, and 30 mg. The product is a one tablet, once-daily patient titration kit for 4 weeks. The label includes dosage instructions by week and states the medication is dispensed in a child-resistant blister pack containing 28 tablets. The labeler is Teva Neuroscience, Inc.*

FDA Label Image

Image (Image 16)

The label for Austedo 6 mg tablets (deutetrabenazine) manufactured by Teva Neuroscience, Inc. It indicates a package size of 60 tablets. The label includes directions to dispense in original or USP-defined container, medication guide requirement, storage instructions at 25°C with permitted excursions, and warnings to protect from light and moisture and keep out of reach of children. A barcode and the revision date of 7/2024 are also visible.*

FDA Label Image

Image (Image 17)

Label for Austedo 9 mg (deutetrabenazine) tablets, manufactured by Teva Neuroscience, Inc. The label indicates a 60-tablet count and includes dosing instructions advising to swallow whole, not to chew, crush, or break. It states the tablet contains 9 mg deutetrabenazine and notes the requirement to dispense with a medication guide. Storage instructions, barcode, and manufacturer location in Parsippany, NJ are also shown.*

FDA Label Image

Image (Image 18)

Label for Austedo 12 mg tablets (deutetrabenazine) by Teva Neuroscience, Inc., containing 60 tablets. The label includes storage instructions, prescription-only status, and a medication guide notice. It features the Teva logo and barcode, with dosage and handling directions.*

FDA Label Image

Image (Image 19)

Austedo Patient Titration Kit packaging label for deutetrabenazine tablets by Teva Neuroscience, Inc. This carton specifies an initial 12 mg starting dose, including strengths 6 mg, 9 mg, 12 mg, and 18 mg over a 4-week titration. The label features dosage details, usage weeks, a barcode, and a QR code on a predominantly purple and white background with green accents.*

FDA Label Image

Hd 4-week Kit (Image 20)

Packaging label for Austedo (deutetrabenazine) tablets 6 mg, 9 mg, 12 mg, a 4 Week Patient Titration Kit with a 6 mg starting dose. The label indicates the product is for chorea associated with Huntington's disease and is distributed by Teva Pharmaceuticals USA, Inc. It includes dosing guidelines, storage conditions, and a QR code for patient support information. The label features the Teva logo and NDC 68546-181-49.*

FDA Label Image

Image (Image 21)

Austedo (deutetrabenazine) tablets packaging label for the Tardive Dyskinesia Titration Pack containing 12 mg starting dose tablets. The label includes strengths 6 mg and 9 mg, marked as a sample not for sale. The labeler is Teva Neuroscience, Inc. Instructions and storage information are visible, along with NDC 68546-176-28 and usage guidelines.*

FDA Label Image

Image (Image 22)

AUSTEDO 6 mg tablets packaging label by Teva Neuroscience, Inc. This label is for a Huntington's disease titration pack with a 6 mg starting dose and displays NDC 68546-177-21. It includes instructions for use and medication guide requirements, emphasizing it is a sample and not for sale.*

* 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.