Intuniv
Product Images NDC 64725-0513

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Intuniv (NDC 64725-0513). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Tya Pharmaceuticals, 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

Label Image (64725 0513)

Packaging label for Intuniv ER 1 mg tablet, containing 100 tablets. The label includes prescription-only status, lot number, expiration date, manufacturer as Shire, and repackager as TYA Pharmaceuticals, Tallahassee, FL. A barcode and a dosing instruction to see the package insert are also visible.*

FDA Label Image

Label Image (64725 0515)

Packaging label for Intuniv 2 mg tablets, repackaged by T.Y.A. Pharmaceuticals located in Tallahassee, FL. The label shows prescription-only status, lot number placeholder, expiration date placeholder, and barcode. The original manufacturer is listed as Shire. Directions refer to the package insert for dosing information.*

FDA Label Image

Figure 1 (Intuniv 01)

A pharmacokinetic chart showing fold changes with 90% confidence intervals for Cmax and AUC of Intuniv affected by CYP3A4 inhibitors Ketoconazole and inducers Rifampin, as well as Oral Methylphenidate and Lisdexamfetamine Dimesylate. The chart includes recommendations like dose reduction for Ketoconazole and dose increase for Rifampin, while no adjustment is required for Methylphenidate or Lisdexamfetamine.*

FDA Label Image

Figure 2 (Intuniv 02)

A chart presenting pharmacokinetic interactions of Intuniv with oral methylphenidate and lisdexamfetamine dimesylate. It shows fold change and 90% confidence intervals for Cmax and AUC parameters, indicating no significant change relative to reference, with recommendations that dose adjustment is not required for either interacting drug.*

FDA Label Image

Spd503-chemical-stucture (Intuniv 03)

Chemical structure diagram of Intuniv hydrochloride, showing its molecular composition with chlorine atoms and functional groups including amide and guanidine moieties.*

* 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.