Extraneal Injection, Solution
Product Images NDC 0941-0707

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Extraneal (NDC 0941-0707). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vantive Us Healthcare Llc, 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

Extraneal Dhcp Letter1 (Image 01)

This image shows an important prescribing information notice dated October 23, 2024, regarding the temporary importation of EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin from Singapore. It details coordination by Baxter Healthcare Corporation with the FDA due to domestic shortages, import specifics including product codes, fill volume, and packaging, and clarifies no clinically relevant differences between the imported and US-manufactured products.*

FDA Label Image

Extraneal Dhcp Letter2 (Image 02)

This text panel provides detailed information about EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis, including differences between products manufactured in Singapore and the US, Luer-lock connector compatibility, barcode scanning issues with imported products, and prescribing information. It also includes instructions for reporting adverse events and product quality issues to Baxter and the FDA.*

FDA Label Image

Extraneal Dhcp Letter 3 (Image 03)

A letter from Baxter Healthcare Corporation providing contact information for questions about EXTRANEAL (icodextrin) Peritoneal Dialysis Solution and ordering instructions. It is signed by Geovana Basso, M.D., Director of Americas Medical Affairs, with official communication details and trademark acknowledgments for Baxter, EXTRANEAL, and UltraBag.*

FDA Label Image

Extraneal Dhcp Letter4 (Image 04)

A comparative data table outlining key differences between the imported EXTRANEAL Peritoneal Dialysis Solution from Singapore and the US FDA approved EXTRANEAL (icodextrin) Peritoneal Dialysis Solution. It covers aspects such as product name, labeled fill volume, container type, bags per carton, indications, active ingredients, electrolyte content per liter, pH, additional information about osmolarity, storage conditions, and expiration dating.*

FDA Label Image

Extraneal Dhcp Letter5 (Image 05)

Comparison diagram showing container closure systems for EXTRANEAL dialysate bags. The left side shows the imported product from Singapore with a green frangible near the solution bag, two online clamps (white on drain line, blue on infusion line), a green pull ring, and a deeply recessed connector cover. The right side displays the US FDA approved product with two frangibles (one blue at the Y junction and one green on the solution bag), no online clamps requiring external clamps, and a purple pull ring.*

FDA Label Image

Extraneal Dhcp Letter6 (Image 06)

A table comparing EXTRANEAL (icodextrin) peritoneal dialysis solution container labels from an imported product in Singapore and the US FDA approved product. The table includes label text and layout differences for the 7.5% icodextrin concentration, manufacturer details, and usage instructions for each label variant.*

FDA Label Image

Representative Extraneal Container Label (FNB4984SG)

EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin, a 2000 mL container labeled by Baxter. The label lists active ingredients including 7.5 g Icodextrin, 538 mg Sodium Chloride, 448 mg Sodium Lactate, 25.7 mg Calcium Chloride, and 5.08 mg Magnesium Chloride per 100 mL. It is sterile, nonpyrogenic, with specified osmolarity and pH. Directions for use, cautions, manufacturer and importer details, storage instructions, and trademarks ULTRABAG and PL-146 are included. The label shows multiple languages including English, Thai, and Chinese.*

FDA Label Image

Representative Extraneal Carton Label (FNB4984SG)

Packaging label for EXTRANEAL 7.5% icodextrin solution in a 2000 mL Ultrabag container. The label includes multiple barcodes, lot number S24A12345, and expiration date 12.12.2024. Labeler is Vantive US Healthcare LLC.*

* 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.