Focalin Capsule, Extended Release
Product Images NDC 66758-239

Product Visual Gallery

This gallery contains 18 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.

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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.*

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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.*

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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.*

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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.*

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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.*

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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.*

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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.*

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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.*

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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.*

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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.*

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5mg30ct (5mg30ct)

Label for Focalin XR 5 mg extended-release capsules, containing dexmethylphenidate hydrochloride, manufactured by Sandoz Inc. The label shows the NDC number 66758-235-31, indicates a 30-capsule package, and includes storage instructions and dispensing requirements along with the Sandoz logo.*

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10mg30ctlabel (1omg30ctlabel)

Label for Focalin XR 10 mg extended-release capsules, containing dexmethylphenidate hydrochloride. The label indicates prescription use, packaging of 30 capsules, and storage instructions at controlled room temperature. Manufactured by Sandoz Inc., with specific manufacturing details included.*

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15mg30ctlabel (15mg30ctlabel)

Label for Focalin XR 15 mg extended-release capsules containing dexmethylphenidate hydrochloride by Sandoz Inc. Package includes 30 capsules. Label includes storage instructions, dispensing requirements, barcode, and manufacturer details with revision date 05/2025.*

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20mg30ctlabel (20mg30ctlabel)

Label for Focalin XR 20 mg extended-release capsules, containing dexmethylphenidate hydrochloride. The label indicates the product is for prescription use only, with a package size of 30 capsules. It includes storage instructions and manufacturer information for Sandoz Inc, with manufacturing by Societal CDMO Gainesville, LLC.*

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25mg30ctlabel (25mg30ctlabel)

Label for Focalin XR 25 mg extended-release capsules containing dexmethylphenidate hydrochloride. The package includes 30 capsules and is labeled for prescription use only. Manufactured by Sandoz Inc, with storage instructions specified from 20°C to 25°C and dispensing in a tight container.*

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30mg30ctlabel (30mg30ctlabel)

Focalin XR 30 mg extended-release capsules label displaying the active ingredient dexmethylphenidate hydrochloride. The label includes dosage form, quantity (30 capsules), and storage instructions. It also lists the NDC 66758-240-31, manufacturer Sandoz Inc, and advises dispensing with the Medication Guide.*

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35mg30ct (35mg30ct)

Label for Focalin XR 35 mg extended-release capsules containing dexmethylphenidate hydrochloride. The label indicates the product is prescription-only, dispensed with a medication guide, and contains 30 capsules. It shows storage instructions and labelers Sandoz Inc and Societal CDMO Gainesville, LLC.*

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40mg30ctlabel (40mg30ctlabel)

Label for Focalin XR 40 mg extended-release capsules containing dexmethylphenidate hydrochloride. The label states 'Rx only' and includes a barcode, storage instructions, and dispensing guidance. It indicates the package contains 30 capsules and is labeled by Sandoz Inc. The label instructs to dispense with the medication guide and includes manufacturer information and revision date.*

* 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.