Hysingla Er Tablet, Extended Release
Product Images NDC 59011-271

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Hysingla Er (NDC 59011-271). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Knoa Pharma Llc, 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

20 mg (303512 0b)

Hysingla ER 20 mg extended-release tablets (hydrocodone bitartrate) package label from Knoa Pharma LLC. The label indicates a supply of 60 tablets with instructions to swallow whole and warnings against cutting or chewing. It includes an NDC number 59011-271-60 and a note that an accompanying Medication Guide must be provided to the patient upon dispensing.*

FDA Label Image

30 mg (303513 0b)

Label for Hysingla ER 30 mg extended-release tablets containing hydrocodone bitartrate. The label indicates the product is a Schedule II controlled substance and contains 60 tablets per bottle. Instructions emphasize swallowing tablets whole without cutting or crushing. The labeler is Purdue Pharma L.P., Stamford, CT, with storage conditions and regulatory information included.*

FDA Label Image

40 mg (303514 0b)

Hysingla ER 40 mg extended-release tablets containing hydrocodone bitartrate. The label indicates 60 tablets per container, prescription only, with instructions to swallow tablets whole without cutting, breaking, chewing, crushing, or dissolving. Manufactured by Purdue Pharma L.P. in Stamford, CT. The label includes a barcode and a warning that a Medication Guide must be provided to the patient upon dispensing.*

FDA Label Image

60 mg (303515 0b)

Label for Hysingla ER 60 mg extended-release tablets (hydrocodone bitartrate) by Knoa Pharma LLC. The label shows the strength as 60 mg and package count as 60 tablets. It includes a dispenser warning to provide the Medication Guide to patients. The label also instructs to swallow tablets whole and not to cut, break, chew, crush, or dissolve them.*

FDA Label Image

80 mg (303516 0b)

Label for Hysingla ER 80 mg extended-release tablets containing hydrocodone bitartrate. The label shows a bottle containing 60 tablets, with instructions to swallow whole and not to cut, break, chew, crush, or dissolve. It includes a dispenser warning about providing a medication guide to patients. The labeler is Purdue Pharma L.P., Stamford, CT.*

FDA Label Image

100 mg (303517 0b)

Hysingla ER 100 mg extended-release tablets (hydrocodone bitartrate) label displaying the product name, strength, dosage form, and quantity of 60 tablets. It notes the requirement for an accompanying Medication Guide upon dispensing and emphasizes swallowing tablets whole. The label also includes storage instructions and the labeler, Knoa Pharma LLC.*

FDA Label Image

120 mg (303518 0b)

Hysingla ER 120 mg extended-release tablets label showing hydrocodone bitartrate as the active ingredient. The label specifies 60 tablets per container, with instructions to swallow tablets whole and a caution that the medication guide must be provided to the patient upon dispensing. The label indicates it is for prescription use only and includes storage instructions and a barcode. Labeler is Knoa Pharma LLC.*

FDA Label Image

Figure-1 (Figure 1)

A line graph showing the percentage of subjects on the y-axis versus the percent reduction in Emax of drug liking for manipulated Hysingla ER compared to powdered hydrocodone following intranasal administration on the x-axis. The chart illustrates a decreasing trend in drug liking reduction as the percent reduction increases from greater than 0 to at least 100.*

FDA Label Image

Figure-2 (Figure 2)

A line graph showing the percentage of subjects experiencing reductions in drug liking Emax for chewed Hysingla ER compared to hydrocodone solution following oral administration. The x-axis represents the percent reduction in Emax from >0 to ≥100, and the y-axis shows the percentage of subjects, decreasing from 80% to about 3% across the range.*

FDA Label Image

Figure-3 (Figure 3)

A line graph comparing hydrocodone plasma concentration (ng/mL) over time (hours) for Hysingla ER 30 mg (one tablet every 24 hours for 3 days) and immediate-release hydrocodone bitartrate 7.5 mg (one tablet every 6 hours for 3 days). The graph shows concentration trends and fluctuations for both formulations across a 24-hour period.*

FDA Label Image

Figure-4 (Figure 4)

A line graph showing cumulative proportion of subjects responding versus percent improvement from screening, comparing treatment groups Hysingla ER and Placebo. The x-axis represents percent improvement from screening in increments from >0 to 100%, and the y-axis shows the cumulative proportion of subjects responding. Two lines indicate response rates for Hysingla ER and Placebo groups, with Hysingla ER consistently higher.*

FDA Label Image

Hydrocodone-bitartrate-structure (Hydrocodone Bitartrate Structure)

Chemical structure of the active ingredient in Hysingla ER, depicted as two molecular diagrams showing the core opioid structure linked to a compound with multiple hydroxyl groups and two and a half water molecules (hydrates).*

* 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.