Extraneal Injection, Solution
Product Images NDC 0941-0719

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Extraneal (NDC 0941-0719). 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 Letter-8 (Iamge 08)

The image shows two versions of the EXTRANEAL Peritoneal Dialysis Solution label by Baxter. Both labels detail it as a 7.5% icodextrin injection solution for intraperitoneal use, with a volume of approximately 2500 ml. The labels list the active ingredients including icodextrin, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride, along with physicochemical properties such as osmolarity and pH. Manufacturer information for Baxter Healthcare and Vantive US Healthcare LLC is included.*

FDA Label Image

Extraneal Dhcp Letter-1 (Image 01)

A prescribing information letter dated October 22, 2024, from Baxter Healthcare Corporation regarding the temporary importation of EXTRANEAL (icodextrin) Peritoneal Dialysis Solution due to US drug shortages. It details import from Baxter's Castlebar, Ireland facility, product codes, NDC codes, carton and bag quantities, and important clinical and regulatory notes.*

FDA Label Image

Extraneal Dhcp Letter-2 (Image 02)

Text excerpt from labeling for EXTRANEAL (icodextrin) peritoneal dialysis solution addressing barcode differences between imported and U.S. products, key packaging distinctions, and instructions for reporting adverse events or product quality issues via phone, fax, or online. It includes references to FDA resources for reporting and prescribing information.*

FDA Label Image

Extraneal Dhcp Letter-3 (Image 03)

A letter signed by Geovana Basso, M.D., Director of Americas Medical Affairs at Baxter Healthcare Corporation, including Baxter's contact address. The letter references trademarks Baxter, Ambu-Flex, and EXTRANEAL, and mentions attached product comparison tables.*

FDA Label Image

Extraneal Dhcp Letter-4 (Image 04)

A detailed data table comparing key differences between the imported EXTRANEAL (icodextrin) solution for peritoneal dialysis from Castlebard, Ireland, and the U.S. FDA-approved EXTRANEAL peritoneal dialysis solution. The table covers product name, fill volume, container type, bags per carton, indications, active ingredients, electrolyte content per liter, pH range, additional information on osmolarity, storage conditions, and expiration dating.*

FDA Label Image

Extraneal Dhcp Letter-5 (Image 05)

A comparison illustration showing two EXTRANEAL injection solution bags. The left bag is labeled as the imported product from Castlebar, Ireland, with a green frangible at the luer-lock connector and a blue protective tip protector. The right bag is labeled as the U.S. FDA approved product, featuring a blue frangible at the luer-lock connector and a purple pull ring cap closure. Both bags are semi-transparent with printed labels and tubing extending from the bottom.*

FDA Label Image

Extraneal Dhcp Letter-6 (Image 06)

Comparison table of EXTRANEAL (icodextrin) peritoneal dialysis solution container labels. It shows two columns: the imported product from Castlebriar, Ireland, and the US FDA approved product, both by Baxter. The table lists detailed formulation and labeling information for the 2000 mL solution, including icodextrin concentration and electrolytes, along with manufacturing and storage instructions.*

FDA Label Image

Extraneal Dhcp Letter-7 (Image 07)

Label for EXTRANEAL Solution for Peritoneal Dialysis, 2000 ml vial from Vantive. The label details the formula per 1000 ml including icodextrin 7.5 g, sodium chloride 5.4 g, sodium (as Na+) 133 mmol/l, calcium (as Ca++) 1.75 mmol/l, magnesium (as Mg++) 0.25 mmol/l, calcium chloride 0.257 g, and magnesium chloride 0.051 g, with osmolality of 284 mOsm/l and pH 5.0–6.0. The label indicates it is an imported product from Castlebar, Ireland, for intraperitoneal use.*

FDA Label Image

Extraneal Dhcp Letter-9 (Image 09)

Label of EXTRANEAL solution for peritoneal dialysis, 2500 ml bottle, imported from Castlebar, Ireland. It lists the active ingredients icodextrin 75 g/L, sodium chloride 5.4 g/L, sodium S-lactate 4.5 g/L, calcium chloride 0.257 g/L, and magnesium chloride 0.051 g/L with corresponding mmol/l values. Additional details include osmolality of 284 mOsm/l, pH 5.0-6.0, and manufacturer information for Vantive Limited, United Kingdom. The label is marked as the Vantive version with storage and usage instructions.*

FDA Label Image

Representative Extraneal Container Label (Image 10)

This text panel details the composition and usage instructions for EXTRANEAL Solution for Peritoneal Dialysis. It lists concentrations of icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and associated electrolytes per 1000 ml. It includes storage, handling, and administration directions, along with manufacturer information for Baxter Healthcare.*

FDA Label Image

Representative Extraneal Carton Label (Image 11)

EXTRANEAL injection solution for peritoneal dialysis, labeled with active ingredients including icodextrin 7.5 g, sodium chloride 5.4 g, sodium (S)-lactate 4.5 g, calcium chloride 0.257 g, magnesium chloride 0.051 g per 1000 ml. The label notes intraperitoneal route, a single bag with a Luer connector, and storage instructions not below 4°C. The labeler is Vantive US Healthcare LLC.*

FDA Label Image

Vantive Representative Extraneal Container Label (Image 12)

This text panel details the formulation and composition of EXTRANEAL Solution for Peritoneal Dialysis by Vantive. It lists ingredient quantities per 1000 ml, including icodextrin 75 g, sodium chloride 5.4 g, sodium (S)-lactate 4.5 g, calcium chloride 0.257 g, magnesium chloride 0.051 g, with water for injection and pH adjustment components. Electrolyte concentrations, osmolarity, and pH range are also provided. Usage instructions and storage conditions are included.*

FDA Label Image

Vantive Representative Extraneal Carton Label (Image 13)

EXTRANEAL solution for peritoneal dialysis in a 2000 mL single bag with Luer connector. The label lists active ingredients per 1000 mL: icodextrin 75 g, sodium chloride 5.4 g, sodium (S)-lactate 4.5 g, calcium chloride dihydrate 0.257 g, magnesium chloride hexahydrate 0.051 g. It is for intraperitoneal use only, not for intravenous infusion, and is labeled by Vantive US Healthcare LLC for UK distribution.*

FDA Label Image

Representative Extraneal Container Label (Image 14)

EXTRANEAL Solution for Peritoneal Dialysis by Baxter is an injection solution for intraperitoneal use. The label lists components per 1000 ml including icodextrin 75 g, sodium chloride 5.4 g, sodium (S)-lactate 4.5 g, calcium chloride 0.257 g, magnesium chloride 0.051 g, with specified ionic concentrations and pH range of 5.0-6.0. Usage and storage instructions, manufacturer Baxter Healthcare Ltd, and Baxter Holding B.V. addresses are also shown.*

FDA Label Image

Representative Extraneal Carton Label (Image 15)

EXTRANEAL solution for peritoneal dialysis, injection solution for intraperitoneal use. The label shows a 2500 ml x 4 packaging with active ingredients including icodextrin 7.5 g, sodium chloride 5.4 g, sodium (S)-lactate 4.5 g, calcium chloride 0.257 g, and magnesium chloride 0.051 g per 1000 ml. It is distributed by Vantive US Healthcare LLC, with storage instructions to keep above 4°C and a single bag with Luer connector.*

FDA Label Image

Vantive Representative Extraneal Container Label (Image 16)

This image shows a formulation and use instructions label for EXTRANEAL Solution for Peritoneal Dialysis, a 2500 ml intraperitoneal injection solution by Vantive. It lists ingredient quantities per 1000 ml, including icodextrin, sodium chloride, sodium lactate, calcium chloride dihydrate, and magnesium chloride hexahydrate, along with electrolyte concentrations, osmolarity, and pH range. The label includes specific storage and usage directions, manufacturer contact information, and regulatory codes.*

FDA Label Image

Vantive Representative Extraneal Carton Label (Image 17)

EXTRANEAL FPB4945R solution for peritoneal dialysis in a 2500 ml x 4 pack. The label lists active ingredients per 1000 ml including icodextrin 75 g, sodium chloride 5.4 g, sodium lactate 4.5 g, calcium chloride 0.257 g, and magnesium chloride 0.051 g. It is for intraperitoneal use only, supplied by Vantive Limited in the UK, and features storage instructions and a barcode.*

* 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.