Hydrocodone Bitartrate Tablet, Extended Release
Product Images NDC 47781-396

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Hydrocodone Bitartrate (NDC 47781-396). 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

Figure-1 (Figure 1)

A line graph depicting the percentage of subjects versus percent reduction in Emax of drug liking for manipulated hydrocodone bitartrate extended-release tablets compared to powdered hydrocodone following intranasal administration. The graph shows a decreasing trend in drug liking reduction as the percentage reduction increases from greater than 0% to 100%.*

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Figure-2 (Figure 2)

A line chart depicting the percentage of subjects versus percent reduction in Emax of drug liking for chewed Hydrocodone Bitartrate extended-release tablets compared to Hydrocodone solution following oral administration. The y-axis shows the percentage of subjects from 0 to 100, and the x-axis shows increasing percent reductions from >0 to >=100, illustrating a downward trend in the percentage of subjects as the percent reduction increases.*

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Figure-3 (Figure 3)

A line graph comparing hydrocodone plasma concentration (ng/mL) over 24 hours for two dosing regimens: Hydrocodone Bitartrate Extended-release Tablets 30 mg taken once every 24 hours for 3 days and immediate-release (IR) Hydrocodone Bitartrate 7.5 mg taken once every 6 hours for 3 days. The graph shows time on the x-axis (0 to 24 hours) and hydrocodone plasma concentration on the y-axis (0 to 40 ng/mL), illustrating fluctuating plasma levels with IR dosing and more stable levels with extended-release dosing.*

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Figure-4 (Figure 4)

A line graph comparing the proportion of subjects responding to treatment versus percent improvement from screening. It shows data for two groups: placebo and Hydrocodone Bitartrate Extended-release Tablets. The x-axis represents percent improvement from screening, and the y-axis represents the proportion of subjects responding (cumulative). The graph includes vertical dashed lines highlighting specific improvement thresholds.*

FDA Label Image

Label-100mg (Hbt Er Tabs 100mg Lbl)

Label for Hydrocodone Bitartrate Extended-Release Tablets 100 mg by Alvogen Inc. The label states it contains 60 tablets and instructs to swallow whole without cutting or crushing. It specifies storage at 25°C (77°F) with allowed excursions, and notes the medication guide must be provided upon dispensing. The product is distributed in the USA by Alvogen, Morristown, NJ.*

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Label-120mg (Hbt Er Tabs 120mg Lbl)

Label for Hydrocodone Bitartrate Extended-Release Tablets, 120 mg strength, in a package of 60 tablets. The label shows the product is distributed by Alvogen Inc., Morristown, NJ, USA, and instructs to swallow tablets whole without cutting, breaking, chewing, crushing, or dissolving. It includes storage instructions to keep between 15° to 30°C and notes the requirement to provide an accompanying Medication Guide to the patient.*

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Label-20mg (Hbt Er Tabs 20mg Lbl)

Label for Hydrocodone Bitartrate Extended-Release Tablets 20 mg, distributed by Alvogen Inc. The label states the active ingredient strength as 20 mg per tablet, with a quantity of 60 tablets. It includes instructions to swallow tablets whole without cutting, breaking, chewing, crushing, or dissolving. Storage instructions specify to store at 25°C (77°F) with excursions permitted between 15° to 30°C, and it indicates prescription-only status.*

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Label-30mg (Hbt Er Tabs 30mg Lbl)

Label for Hydrocodone Bitartrate Extended-Release Tablets 30 mg, oral dosage form. The label indicates 60 tablets per container, distributed by Alvogen Inc., Morristown, NJ. Key instructions include swallowing tablets whole without cutting or crushing and storing at 25°C (77°F) with permitted excursions. The label also mentions that a medication guide must be provided to the patient upon dispensing.*

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Label-40mg (Hbt Er Tabs 40mg Lbl)

Hydrocodone Bitartrate Extended-Release Tablets 40 mg carton label from Alvogen Inc. The label displays dosage strength, tablet count of 60, and includes storage instructions, dispensing warnings, and a barcode. It specifies the product is distributed by Alvogen, Inc., Morristown, NJ, USA.*

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Label-60mg (Hbt Er Tabs 60mg Lbl)

Label for Hydrocodone Bitartrate Extended-Release Tablets 60 mg from Alvogen Inc. The label includes dosage instructions to swallow tablets whole without cutting or crushing. The package contains 60 tablets, for prescription use only, and advises dispensing with an accompanying medication guide. Storage instructions specify 25°C with permitted excursions between 15° to 30°C.*

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Label-80mg (Hbt Er Tabs 80mg Lbl)

Label for Hydrocodone Bitartrate extended-release tablets, 80 mg strength, oral dosage form. The label indicates a 60 tablet count, distributed by Alvogen Inc. It includes usage instructions such as swallowing tablets whole and storage conditions at controlled room temperature. The label also highlights the requirement to provide an accompanying Medication Guide upon dispensing.*

FDA Label Image

Structure (Structure)

Chemical structure diagram showing the molecular structures of Hydrocodone Bitartrate along with associated components and water of hydration (5/2 H2O molecules).*

* 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.