Guanfacine Extended-release Tablet, Extended Release
Product Images NDC 60505-3930

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Guanfacine Extended-release (NDC 60505-3930). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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 comparing plasma concentration (ng/mL) of guanfacine over 24 hours (Time, hr) between extended-release and immediate-release guanfacine, both at 1 mg QD. The extended-release formulation shows a lower peak and more sustained plasma concentration, while the immediate-release has a higher peak and declines faster.*

FDA Label Image

Figure-2 (Figure 2)

A forest plot chart showing the pharmacokinetic (PK) fold change and 90% confidence intervals (CI) for Cmax and AUC values of Guanfacine extended-release when co-administered with various CYP3A4/5 inhibitors and inducers, including ketoconazole, fluconazole, rifampin, efavirenz, oral methylphenidate, and lisdexamfetamine dimesylate. The x-axis represents change relative to reference.*

FDA Label Image

Figure-3 (Figure 3)

A chart depicting fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of oral methylphenidate and lisdexamfetamine dimesylate relative to a reference. The x-axis shows change relative to the reference from 0.0 to 2.0, with plotted points near 1.0.*

FDA Label Image

Figure4.jpg (Figure4)

A line graph showing treatment failure percentage over time in days for Guanfacine extended-release compared to placebo. The x-axis represents time to treatment failure in days from 0 to about 200, and the y-axis shows treatment failure percentage from 0% to 100%. Two lines are plotted: a solid line for placebo and a dashed line for SPD503 (Guanfacine).*

FDA Label Image

Btl 1mg100s

Label for Guanfacine Extended-Release Tablets 1 mg, containing 100 tablets. The label shows storage instructions, usage notes, and manufacturer details. It is produced by Apotex Inc., Toronto, Canada, and manufactured for Apotex Corp., Weston, Florida. The NDC on the label is 60505-3927-1.*

FDA Label Image

Btl 2mg100s

Label for Guanfacine extended-release tablets containing 2 mg guanfacine hydrochloride per tablet. The label indicates a count of 100 tablets, with storage instructions between 20°C to 25°C. Manufactured by Apotex Inc., Toronto, Ontario, Canada, and labeled for Apotex Corp., Weston, Florida. The label includes an NDC number 60505-3928-1 and a barcode.*

FDA Label Image

Btl 3mg100s

Label for Guanfacine Extended-Release Tablets 3 mg by Apotex Corp. The package contains 100 tablets. Storage instructions include keeping at 20°C to 25°C with allowed excursions, protecting from moisture, and dispensing in a tight container. The label advises tablets should not be crushed, chewed, or broken before swallowing and includes a barcode and manufacturer information.*

FDA Label Image

Btl 4mg100s

Label for Guanfacine extended-release tablets, 4 mg strength, oral dosage form. The label indicates packaging for 100 tablets. It includes storage instructions and manufacturer information for Apotex Corp., with manufacturing locations in Toronto, Ontario, and Weston, Florida. The label features a barcode and cautions about tablet handling.*

FDA Label Image

Spd503-chemical-stucture (Spd503 Chemical Stucture)

Chemical structure of guanfacine hydrochloride, showing its molecular formula with chlorine atoms and the hydrochloride salt indicated.*

* 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.