Focalin Capsule, Extended Release
Product Images NDC 66758-237

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Focalin (NDC 66758-237). 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)

Focalin XR 10 mg extended-release capsules label, containing 100 capsules. The label shows the active ingredient dexmethylphenidate HCl and includes storage instructions, dispensing guidance, manufacturer details (Societal CDMO Gainesville, LLC for Sandoz Inc.), and barcode information. This prescription drug packaging is from Sandoz Inc.*

FDA Label Image

15mglabel (15mglabel)

Focalin XR 15 mg extended-release capsules, containing dexmethylphenidate hydrochloride. This prescription drug label shows a bottle of 100 capsules manufactured by Sandoz Inc. The label includes dosage and storage instructions, cautions to keep out of reach of children, and manufacturing details for Sandoz facilities in Alabama and New Jersey.*

FDA Label Image

20mglabel (20mglabel)

Focalin XR 20 mg extended-release capsules label from Sandoz Inc. The label includes the proprietary name, generic name dexmethylphenidate hydrochloride, NDC 66758-238-01, and indicates the package contains 100 capsules. It notes the product is Rx only and provides storage instructions and manufacturer information.*

FDA Label Image

25mglabel (25mglabel)

Focalin XR 25 mg extended-release capsules, dexmethylphenidate HCl, in a 100-capsule container. The label includes storage instructions, medication guide dispensing information, and manufacturer details for Sandoz Inc and Societal COMO Gainesville, LLC.*

FDA Label Image

30mglabel (30mglabel)

Label for Focalin XR 30 mg extended-release capsules containing dexmethylphenidate hydrochloride by Sandoz Inc. The label includes NDC 66758-240-01, a schedule II controlled substance mark, and directions to dispense 100 capsules with a medication guide. Storage instructions specify 20°C to 25°C with permitted excursions, and manufacturer details are listed.*

FDA Label Image

35mglabel (35mglabel)

Label for Focalin XR 35 mg extended-release capsules containing dexmethylphenidate hydrochloride, with 100 capsules per container. The label includes storage instructions, dispensary guidelines, and mentions the manufacturer Sandoz Inc. The medication is labeled Rx only and dispensed with a Medication Guide.*

FDA Label Image

40mglabel (40mglabel)

Label for Focalin XR 40 mg extended-release capsules, containing dexmethylphenidate hydrochloride. The label indicates a 100-capsule count, prescription only, and storage instructions between 20°C to 25°C. Manufactured by Societal CDMO Gainesville for Sandoz Inc.*

FDA Label Image

5mglabel (5mglabel)

The label for Focalin XR 5 mg extended-release capsules by Sandoz Inc. It shows the proprietary name with the generic name dexmethylphenidate HCl, a dosage strength of 5 mg, and package quantity of 100 capsules. Storage and dispensing instructions, the NDC number 66758-235-01, and manufacturer details are also visible.*

FDA Label Image

Dexmethylphenidate Hydrochloride Structural Formula. (Focalin Xr 01)

Chemical structure diagram of dexmethylphenidate hydrochloride, the active ingredient in Focalin XR. The diagram shows the molecular arrangement including the piperidine ring, phenyl group, and ester functional group characteristic of dexmethylphenidate.*

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)

A pharmacokinetic curve graph comparing dexmethylphenidate concentration (ng/mL) over time (hours) for Focalin XR 20 mg extended-release capsules versus Focalin IR 2 x 10 mg immediate-release doses. The graph shows concentration peaks and decline over 24 hours, illustrating absorption and elimination profiles.*

* 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.