Lurasidone Hydrochloride Tablet, Film Coated
Product Images NDC 16729-348

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Lurasidone Hydrochloride (NDC 16729-348). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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

Chemical Structure (Lurasidone Str)

Chemical structure of lurasidone hydrochloride, showing its molecular arrangement including multiple rings and functional groups relevant to the active pharmaceutical ingredient lurasidone hydrochloride.*

FDA Label Image

Figure 1 (Lurasidone Fig1)

A chart titled 'Impact of other drugs on Lurasidone Pharmacokinetics (PK)' showing fold changes and 90% confidence intervals in Cmax and AUC values for lurasidone when coadministered with interacting drugs. The chart categorizes drugs as strong CYP3A4 inhibitors (Ketoconazole), moderate CYP3A4 inhibitors (Diltiazem), and strong CYP3A4 inducers (Rifampin, Lithium). The x-axis represents change relative to lurasidone alone, ranging from -4 to 4.*

FDA Label Image

Figure 2 (Lurasidone Fig2)

A forest plot showing fold change and 90% confidence intervals in pharmacokinetic parameters (Cmax, AUC, Ctrough) of various interacting drugs relative to the drug alone. The chart compares P-gp substrates (digoxin), CYP3A4 substrates (midazolam), oral contraceptives (ethinyl estradiol, norelgestromin), and lithium with lurasidone hydrochloride interaction effects on drug exposure.*

FDA Label Image

Figure 3 (Lurasidone Fig3)

A pharmacokinetic plot showing fold change and 90% confidence intervals for Cmax and AUC under different conditions of renal and hepatic impairment and population subgroups (gender, race). The x-axis indicates change relative to reference, with data points and error bars representing variability and comparisons to a reference group.*

FDA Label Image

Lurasidone Hydrochloride 20 mg-30 Tablets-label (Lurasidone 20mg 30)

Label for Lurasidone Hydrochloride Tablets 20 mg film-coated oral tablets. The label shows the product name, strength, and tablet count of 30. It includes storage instructions and manufacturer details, noting Accord Healthcare, Inc. as the labeler and Intas Pharmaceuticals Limited as the manufacturer. The label has two barcodes and a designated varnish free area.*

FDA Label Image

Lurasidone Hydrochloride 40 mg-30 Tablets-label (Lurasidone 40mg 30)

Label for lurasidone hydrochloride tablets 40 mg by Accord Healthcare, Inc. The film-coated tablets are prescription only, provided in a package of 30 tablets. The label includes storage instructions (store at 25°C with permitted excursions), manufacturer details, and a note for pharmacists to dispense the medication guide with the product. The label also features barcodes and a varnish free area.*

FDA Label Image

Lurasidone Hydrochloride 60 mg-30 Tablets-label (Lurasidone 60mg 30)

Label for Lurasidone Hydrochloride Tablets 60 mg, film-coated oral tablets. The label indicates the product contains 30 tablets, is for prescription use only, and advises pharmacists to dispense the enclosed Medication Guide. It is manufactured for Accord Healthcare, Inc., Durham, NC, with the manufacturing license from Intas Pharmaceuticals Limited, India. Storage instructions and an NDC number are also shown.*

FDA Label Image

Lurasidone Hydrochloride 80 mg-30 Tablets-label (Lurasidone 80mg 30)

Label for Lurasidone Hydrochloride Tablets 80 mg film-coated oral tablets by Accord Healthcare, Inc. The label states the dosage strength as 80 mg, prescription only, packaging contains 30 tablets, and includes storage instructions to keep at 25°C with permitted excursions. Manufacturer information includes Intas Pharmaceuticals Limited, India.*

FDA Label Image

Lurasidone Hydrochloride 120 mg-30 Tablets-label (Lurasidone 120mg 30)

Lurasidone Hydrochloride 120 mg film coated tablets label showing the brand and generic name, strength, oral route, and package size of 30 tablets. The label includes storage instructions (store at 25°C with permitted excursions), manufacturer details (Intas Pharmaceuticals Limited, India), and labeler information (Accord Healthcare, Inc.). It indicates prescription-only status and directs the pharmacist to dispense the enclosed medication guide.*

* 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.