Focalin Capsule, Extended Release
Product Images NDC 66758-239

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Focalin (NDC 66758-239). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

10mglabel (10mglabel)

FDA Label Image

15mglabel (15mglabel)

This text provides important information about Focalin XR® (dexmethylphenidate HCI) extended-release capsules, including the NDC code, dosage information, and storage instructions. It mentions the manufacturer as Sucampo Pharmaceuticals LLC and includes a directive to dispense with the Medication Guide. It is essential to handle the medication properly and store it at controlled room temperature.*

FDA Label Image

20mglabel (20mglabel)

FDA Label Image

25mglabel (25mglabel)

This is a description of medication Focalin XR (dexmethylphenidate HCI) 10mg extended-release capsules. The dosage instructions state to store the capsules between 15°C and 30°C (59°F and 86°F) and to keep them out of reach of children. It is advised to dispense the capsules in a tight container as per USP guidelines and include the Medication Guide when dispensing. The address of the manufacturer, SANDOZ, is also provided.*

FDA Label Image

30mglabel (30mglabel)

This text appears to be a prescription label for Focalin XR (dexmethylphenidate HCI) extended-release capsules. The label provides information on dosage, storage instructions, manufacturer details, and a reminder to keep drugs out of reach of children. It instructs to dispense in a tight container with the medication guide attached or provided separately. It is manufactured by Socital CDMO Gainesville, LLC for Sandoz Inc. Please consult the package insert for specific dosage instructions.*

FDA Label Image

35mglabel (35mglabel)

FDA Label Image

40mglabel (40mglabel)

This is a description for Focalin XR® extended-release capsules. The medication contains dexmethylphenidate HCI and is intended for prescription use only. It is advised to store the capsules between 20°C to 25°C (68°F to 77°F) and excursions are permitted between 15°C and 30°C (59°F and 86°F). The drug should be kept out of reach of children and dispensed in a tight container. It is important to refer to the package insert for dosage instructions and the Medication Guide for additional information. This product is distributed by Sandoz LLC.*

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5mglabel (5mglabel)

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Dexmethylphenidate Hydrochloride Structural Formula. (Focalin Xr 01)

FDA Label Image

Figure 1 Mean Dexmethylphenidate Plasma Concentration-time Profiles After Administration Of 1 X 20 mg Focalin Xr (n=24) Capsules And 2 X 10 mg Focalin Immediate-release Tablets (n=25). (Focalin Xr 02)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.