Chemical Structure (Xenleta 01)
Xenleta
Product Images NDC 72000-110
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Xenleta (NDC 72000-110). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Nabriva Therapeutics Us, 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.
Injection Vial Label (Xenleta 02)
NDC 72000-120-01 R.only Xenleta (lefamulin) injection is a concentrated solution containing 150 mg/15 mL of Lefamulin. Each single-dose vial of the solution contains 168 mg Lefamulin acetate equivalent to 150 mg Lefamulin. The solution is sterile, non-pyrogenic, and intended for intravenous infusion only. The package insert includes dilution instructions and complete information on dosage and administration. The solution must be refrigerated and protected from freezing. The lot number is 12345, and the expiration date is MMM_YYYY.*
Injection Carton Label (Xenleta 03)
This is a medication information sheet for Xenleta (lefamulin) injection which is used for intravenous infusion only. The text includes warnings for this concentrated solution that must be diluted before use. Each vial of 150 mg/15 mL contains 168 mg lefamulin acetate. The manufacturer, Nabriva Therapeutics US, recommends diluting 15 mL concentrate in 250 mL of 10 mM citrate buffered 0.9% sodium chloride for injection that they provide. The text notes that the medication is sterile and non-pyrogenic and should be stored refrigerated at 2°C to 8°C. The page also mentions the lot number, expiry date, and unique identifiers of the product.*
Diluent Bag Label (Xenleta 04)
This is a diluent solution for Xenleta (Lefamulin) injection which carries NDC 72000-030-01. The solution contains 10 mM Citrate buffered 0.9% Sodium Chloride. The instructions advise infusing over 60 minutes and list the electrolytes per 1000 mL as Sodium 174 mEq and Chloride 154 mEq. The pH is 4.5-5.5 and it is sterile, non-pyrogenic. Note that the solution must be used within 24 hours at room temperature and up to 48 hours refrigerated. The solution comes in a single-dose container and must not be used in series connections. The dosage instructions should be checked.*
Diluent Carton Label (Xenleta 05)
This text contains a mixture of different information with most of it being unreadable due to errors. From the readable parts, it seems to be a warning for a medication for intravenous infusion only, with the medication named "YENLETA{LEFAMULIN]RUECTON". It also includes information about the diluent to be used during the infusion. The text also includes some numerical codes which might be useful for referencing. However, due to the majority of the text being unreadable, it is difficult to provide a precise description.*
Tablet 30-count Bottle Label (Xenleta 06)
GTIN 00372000110301 corresponds to Xenleta (lefamulin) tablets which contain 600 mg lefamulin acetate equivalent to 600 mg lefamulin in each tablet. The package includes 30 tablets intended to be stored at a temperature between 20°C to 25°C (68°F to 77°F). Dispense in tight (USP), child-resistant containers. For dosage and administration, refer to the accompanying full prescribing information. The manufacturer is Nabriva Therapeutics US, Inc. The expiration date is not available from the provided text.*
Xenleta 07
This text appears to be a combination of various text fragments and does not form a coherent description. Therefore, it is not possible to generate a useful description from this text.*
* 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.
