Dianeal Low Calcium With Dextrose
Product Images NDC 0941-0715

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Dianeal Low Calcium With Dextrose (NDC 0941-0715). 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

Dianeal Dhcp 1 (Image 01)

This document provides important prescribing information dated October 22, 2024, regarding the temporary importation of DIANEAL PD-4 Low Calcium Peritoneal Dialysis Solutions with Dextrose at concentrations of 1.5%, 2.5%, and 4.25% for Continuous Ambulatory Peritoneal Dialysis (CAPD) use. It details coordination by Baxter Healthcare Corporation with the FDA for importing these products from Thailand due to U.S. shortages, including NDC codes and packaging details for bags of 2000 mL each. Safety information on calcium content differences compared to other DIANEAL products is also included.*

FDA Label Image

Dianeal (DHCP 2)

A text panel discussing clinical differences, labeling, and usage instructions for DIANEAL Low Calcium Peritoneal Dialysis Solution with Dextrose, including information on US vs. Thailand manufactured products, container packaging, barcode issues, and adverse event reporting instructions. It highlights compatibility features and prescribing notes for healthcare providers.*

FDA Label Image

Dianeal (DHCP 3)

This document is a formal letter from Baxter Healthcare Corporation providing reporting instructions for product quality issues related to DIANEAL Peritoneal Dialysis Solution by Vantive US Healthcare LLC. It includes contact information, references to FDA prescribing information, and official signatures. The letter addresses inquiries and order placement for DIANEAL Low Calcium Peritoneal Dialysis Solution.*

FDA Label Image

Dianeal (DHCP 4)

A comparison table detailing key differences of DIANEAL Peritoneal Dialysis Solution products for CAPD therapy from Thailand and US FDA-approved versions. It covers product names, labeled fill volumes, container types, bags per carton, indications, active ingredients (Dextrose and electrolytes), and electrolyte content per liter for different dextrose concentrations and formulations.*

FDA Label Image

Dianeal (DHCP 5)

A data table comparing Thailand Imported Product DIANEAL PD-4 Low Calcium, US FDA-Approved DIANEAL Low Calcium, and US FDA-Approved DIANEAL PD-2. It details pH values, additional information about dextrose concentration and osmolality, storage conditions, expiration dating, container closure systems with photos, and container closure differences including color-coded pull ring caps and fragility of components.*

FDA Label Image

Dianeal (DHCP 6)

A data table comparing container labels for DIANEAL Low Calcium peritoneal dialysis (PD) solutions intended for Continuous Ambulatory Peritoneal Dialysis (CAPD). The table includes labels for the 2000 mL Thailand imported product, the US FDA-approved 2000 mL product with 2.5 mEq/L low calcium and 1.5% dextrose, and the US FDA-approved DIANEAL PD-2 product with 1.5% dextrose. The comparison highlights label layout, ingredient quantities, and product information such as container type and manufacturer details.*

FDA Label Image

Dianeal (DHCP 7)

DIANEAL Low Calcium with 2.5% Dextrose peritoneal dialysis solutions by Baxter. The image shows three product labels: DIANEAL PD-4 Low Calcium with 2.5% Dextrose (2000 mL) imported from Thailand, DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose (2000 mL), and DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose (2000 mL) both FDA-approved. Labels present strength details, usage instructions, and manufacturer information including Baxter and Vantive US Healthcare LLC.*

FDA Label Image

Dianeal (DHCP 8)

Label set for DIANEAL Low Calcium Peritoneal Dialysis Solutions by Baxter. Includes Thailand imported DIANEAL PD-4 Low Calcium 2000 mL and US FDA-approved DIANEAL Low Calcium PD Solution (2.5 mEq/L) and DIANEAL PD-2 Peritoneal Dialysis Solution, both 2000 mL with 4.25% Dextrose. Labels show ingredients, caution notices, manufacturer information, and use instructions.*

FDA Label Image

Dianeal Representative Container Label Thb9766 (0941-0711.jpg)

Label for DIANEAL PD-4 Low Calcium with 1.5% Dextrose solution by Baxter, presented in a 2000 mL volume bag. The label lists active ingredients per 100 mL including sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. It specifies the pH range, osmolality, and directions for storage below 30°C. Manufactured by Baxter Manufacturing (Thailand) Co., Ltd., Rayong, Thailand.*

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Dianeal Representative Carton Label Thb9766 (0941-0711)

DIANEAL LOW CALCIUM WITH DEXTROSE 1.5% sterile, nonpyrogenic solution, supplied as 6 units of 2000 mL each. The label lists active ingredients per 100 mL: Dextrose Hydrous USP 1.5 g, Sodium Chloride USP 538 mg, Sodium Lactate 448 mg, Calcium Chloride USP 18.3 mg, Magnesium Chloride USP 5.08 mg. Manufactured by Baxter Manufacturing (Thailand) Co., Ltd., Rayong, Thailand. Includes batch number, manufacturing date (7 Jan 2020), and expiration date (7 Jan 2022).*

FDA Label Image

Dianeal Representative Container Label Thb9776 (Image 11)

Label for Dianeal PD-4 Low Calcium with 2.5% Dextrose peritoneal dialysis solution by Baxter, showing a 2000 mL container. The label lists active ingredients including dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride with their respective strengths. It includes storage instructions, cautionary notes, and manufacturer information from Baxter Manufacturing (Thailand) Co., Ltd., Rayong, Thailand.*

FDA Label Image

Dianeal Representative Carton Label Thb9776 (Image 12)

Label for Dianeal PD-4 Low Calcium with 2.5% Dextrose, a sterile nonpyrogenic solution in a 6 x 2000 mL package. Contains Dextrose 2.5 g, Sodium Chloride 538 mg, Sodium Lactate 448 mg, Calcium Chloride Dihydrate 18.3 mg, Magnesium Chloride Hexahydrate 5.08 mg per 100 mL. Manufactured by Baxter Manufacturing (Thailand) Co., Ltd.*

FDA Label Image

Dianeal Representative Container Label Thb9796ip (Image 13)

Label for Baxter DIANEAL LOW CALCIUM WITH DEXTROSE peritoneal dialysis solution, 2000 ml bottle. The label details composition including dextrose, sodium chloride, calcium chloride, magnesium chloride, sodium citrate, and lactate with osmolarity 483 mOsmol/L. It specifies product use instructions, storage conditions below 30°C, and denotes it as sterile and non-pyrogenic. Manufactured by Baxter Manufacturing (Thailand) Co., Ltd. with importer information for Baxter India Pvt. Ltd.*

FDA Label Image

Dianeal Representative Carton Label Thb9796ip (Image 14)

Label for DIANEAL LOW CALCIUM WITH DEXTROSE peritoneal dialysis solution low calcium with 4.25% dextrose, showing ingredient amounts per 100 mL such as Dextrose Hydrous 4.25 g, Sodium Chloride 538 mg, Sodium Lactate 448 mg, Calcium Chloride Dihydrate 18.3 mg, and Magnesium Chloride Hexahydrate 5.08 mg. It states sterile, nonpyrogenic solution, storage below 30°C, batch number, manufacturing and expiration dates, net quantity of 6 bags of 2000 mL, manufacturer Baxter Manufacturing (Thailand) Co., Ltd., and importer Baxter (India) Pvt. Ltd.*

* 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.