Focalin Capsule, Extended Release
Product Images NDC 0078-0432

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Focalin (NDC 0078-0432). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novartis Pharmaceuticals Corporation, 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

Dexmethylphenidate Hydrochloride Structural Formula. (Focalin Xr 01)

Chemical structure diagram of dexmethylphenidate hydrochloride, the active ingredient in Focalin XR. The structure shows a bicyclic piperidine ring, a phenyl group, and functional groups including a methyl ester and hydrochloride salt.*

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 line graph comparing plasma concentration of dexmethylphenidate over time for Focalin XR 20 mg extended release (filled circles) versus Focalin IR 2 x 10 mg immediate release (open circles). The x-axis shows time in hours up to 24, and the y-axis shows dexmethylphenidate concentration in ng/mL, demonstrating concentration changes over time for both formulations.*

FDA Label Image

Principal Display Panel Ndc 0078-0430-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 5 mg 100 Capsules Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 03)

Focalin XR 5 mg extended-release capsules containing dexmethylphenidate hydrochloride. The label displays the NDC 0078-0430-05 and indicates a package size of 100 capsules. It includes storage instructions, dosage reference to package insert, and manufacturer information for Novartis Pharmaceuticals Corporation, East Hanover, NJ, and Rocro Gainesville LLC, Gainesville, GA.*

FDA Label Image

Principal Display Panel Ndc 0078-0431-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 10 mg 100 Capsules Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 04)

Label for Focalin XR 10 mg extended-release capsules containing dexmethylphenidate hydrochloride. The label indicates 100 capsules per package, prescription only, with storage instructions and manufacturer details for Novartis Pharmaceuticals Corporation and Recro Gainesville LLC. It advises dispensing with the Medication Guide.*

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Principal Display Panel Ndc 0078-0493-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 15 mg 100 Capsules Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 05)

Focalin XR 15 mg extended-release capsules label showing the active ingredient dexmethylphenidate hydrochloride. The label specifies a bottle containing 100 capsules, with instructions to dispense with a Medication Guide. It is manufactured by Novartis Pharmaceuticals Corporation and includes storage and dosage directions.*

FDA Label Image

Principal Display Panel Ndc 0078-0432-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 20 mg 100 Capsules Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 06)

Label for Focalin XR 20 mg extended-release capsules containing dexmethylphenidate hydrochloride. The bottle contains 100 capsules and is labeled for prescription use only. The label includes storage instructions to keep the capsules at 20°C to 25°C, with permitted excursions between 15°C to 30°C. Manufactured for Novartis Pharmaceuticals Corporation.*

FDA Label Image

Principal Display Panel Ndc 0078-0608-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 25 mg 100 Capsules Dispense In Tight Container (usp). Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 07)

Focalin XR 25 mg extended-release capsules label by Novartis Pharmaceuticals Corporation. The label indicates the product contains dexmethylphenidate hydrochloride, with a quantity of 100 capsules per container. It includes storage instructions and notes that the medication guide should be dispensed with the product. The label is marked Rx only and features the Novartis logo.*

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Principal Display Panel Ndc 0078-0433-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 30 mg 100 Capsules Dispense In Tight Container (usp). Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 08)

Focalin XR 30 mg extended-release capsules label showing the active ingredient dexmethylphenidate hydrochloride. The label indicates a package of 100 capsules with dispensing instructions to keep in a tight container (USP) and to include a Medication Guide. Storage instructions specify 20°C to 25°C with allowed excursions, and the product is manufactured for Novartis Pharmaceuticals Corporation.*

FDA Label Image

Principal Display Panel Ndc 0078-0609-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 35 mg 100 Capsules Dispense In Tight Container (usp). Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 09)

Focalin XR 35 mg extended-release capsules packaging label showing the active ingredient dexmethylphenidate HCl. The label includes the quantity of 100 capsules, storage instructions, and dispensing guidance. It also displays the Novartis Pharmaceuticals Corporation as the manufacturer with relevant regulatory and barcode information.*

FDA Label Image

Principal Display Panel Ndc 0078-0434-05 Rx Only Focalin Xr® (dexmethylphenidate HCl) Extended-release Capsules 40 mg 100 Capsules Dispense In Tight Container (usp). Dispense With Medication Guide Attached Or Provided Separately. Novartis (Focalin Xr 10)

Label for Focalin XR 40 mg extended-release capsules, containing dexmethylphenidate hydrochloride. The label indicates 100 capsules in a tight container, with storage instructions and dispensing information. Manufactured for Novartis Pharmaceuticals Corporation.*

* 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.