Lurasidone Hydrochloride Tablet, Coated
Product Images NDC 68382-965

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Lurasidone Hydrochloride (NDC 68382-965). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa 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

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 01)

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 01)
Chemical structure of Lurasidone hydrochloride, showing its detailed molecular arrangement including fused ring systems and a hydrochloride moiety, consistent with its structure as an oral coated tablet formulation by Zydus Pharmaceuticals USA Inc.*
FDA Label Image

Figure 1 (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 02)

Figure 1 (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 02)
A pharmacokinetic impact chart showing fold change and 90% confidence intervals of Lurasidone concentrations when co-administered with other drugs. The x-axis represents change relative to Lurasidone alone. The y-axis lists interacting drugs categorized as strong CYP3A4 inhibitors, moderate CYP3A4 inhibitors, and strong CYP3A4 inducers, including Ketoconazole, Diltiazem, Rifampin, and Lithium, illustrating their effect on Cmax and AUC of Lurasidone.*
FDA Label Image

Figure 2 (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 03)

Figure 2 (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 03)
A fold change and 90% confidence interval chart showing pharmacokinetic interactions of various interacting drugs with lurasidone hydrochloride. The x-axis represents the change relative to the interactive drug alone, and the y-axis lists drugs including Digoxin, Midazolam, Ethinyl Estradiol, Norelgestromin, and Lithium, with pharmacokinetic parameters (Cmax, AUC, Ctrough) indicated. Data points and error bars show the extent of interaction effects.*
FDA Label Image

Figure 3 (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 04)

Figure 3 (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 04)
A fold change graph with 90% confidence intervals showing pharmacokinetic (PK) parameters Cmax and AUC variations relative to a reference. It categorizes data by renal impairment (mild, moderate, severe), hepatic impairment (mild, moderate, severe), and population descriptors including gender (females) and race (Asian), illustrating changes in Lurasidone hydrochloride exposure levels.*
FDA Label Image

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 05)

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 05)
Label for Lurasidone Hydrochloride Tablets 20 mg, oral coated tablets, supplied in a 30-tablet package. Label indicates Rx only and includes NDC 68382-965-06. Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. Storage instructions and child safety warnings are present, along with a pharmacist notice to dispense the Medication Guide.*
FDA Label Image

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 06)

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 06)
Lurasidone Hydrochloride Tablets 40 mg coated oral tablets label showing dosage strength, package quantity of 90 tablets, and dispensing instructions for pharmacists. Labeled with manufacturer Zydus Lifesciences Ltd., Ahmedabad, India, and distributor Zydus Pharmaceuticals USA Inc., Pennington, NJ. Includes storage instructions and child-resistant packaging notice.*
FDA Label Image

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 07)

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 07)
Lurasidone Hydrochloride Tablets 60 mg label showing a bottle of 30 coated tablets. The label states it is prescription only, child-resistant packaging, and includes storage instructions at 20° to 25°C. Manufactured by Zydus Lifesciences Ltd., India, and distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ. The label also includes a barcode, pharmacist dispensing instructions, and contact information for the medication guide.*
FDA Label Image

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 08)

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 08)
Label for Lurasidone Hydrochloride Tablets, 80 mg strength, coated oral tablets. The label states a count of 30 tablets per package and includes dispensing instructions for pharmacists. Manufactured by Zydus Lifesciences Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc. in New Jersey. Storage and safety warnings are present.*
FDA Label Image

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 09)

Lurasidone Hydrochloride Tablets (Fe8f0414 B5f4 4714 A202 D04f4ed321fa 09)
Label for Lurasidone Hydrochloride Tablets 120 mg by Zydus Pharmaceuticals USA Inc. The label displays the product name, strength (120 mg), dosage form (tablets), package count (30 tablets), and Rx only status. It includes usage instructions, storage information, manufacturer details (Zydus Lifesciences Ltd., India), and distributor information (Zydus Pharmaceuticals USA in New Jersey). A barcode and revision date (05/22) also appear.*

* 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.