Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0684

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 0941-0684). 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 Letter 1 (Image 01)

This prescribing information letter from Baxter dated October 21, 2024, announces the temporary importation of DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with Dextrose from China to address drug shortages. The letter details product descriptions, CAPD fill volume (2500 mL), product codes, bags per carton, NDC codes, and notes caution about serum calcium monitoring for patients receiving imported solution.*

FDA Label Image

Dianeal Dhcp Letter 2 (Image 02)

Text panel comparing U.S. and China-manufactured DIANEAL Low Calcium with Dextrose Peritoneal Dialysis Solutions, highlighting differences in drug composition, packaging, Luer-lock connector design, barcode readability in U.S. systems, and labeling. Includes instructions for reporting adverse events to FDA and Baxter contact information.*

FDA Label Image

Dianeal Dhcp Letter 3 (Image 03)

A formal letter from Baxter Healthcare Corporation containing contact information for product quality issues and ordering details for DIANEAL Low Calcium Peritoneal Dialysis Solution. It references FDA-approved prescribing information and includes an electronic signature from Geovana Basso, M.D., Director of Americas Medical Affairs.*

FDA Label Image

Dianeal Dhcp Letter 4 (Image 04)

A comparative data table titled 'Key differences of DIANEAL Peritoneal Dialysis Solution for CAPD therapy' from Baxter. It contrasts three product categories: imported DIANEAL Low Calcium from Guangzhou, China; U.S. FDA-approved DIANEAL Low Calcium; and U.S. FDA-approved DIANEAL PD-2. The table details product names, labeled fill volumes, container types, bags per carton, indications, active ingredients (dextrose and electrolytes), electrolyte content per liter with low calcium, pH values, and additional osmolarity information.*

FDA Label Image

Dianeal Dhcp Letter 5 (Image 05)

A comparison table showing storage conditions, expiration dating, container closure systems, container closure differences, and bag print color for three products: Imported Product DIANEAL Low Calcium from Guangzhou, China; U.S. FDA-Approved DIANEAL Low Calcium; and U.S. FDA-Approved DIANEAL PD-2. The table includes images of the containers, descriptions of clamp and frangible configurations, and specific colors for dextrose concentrations on the solution bags.*

FDA Label Image

Dianeal Dhcp Letter 6 (Image 06)

Table comparing DIANEAL PD Solution container labels for CAPD from three sources: imported product (Guangzhou, China), US FDA approved DIANEAL Low Calcium PD Solution, and US FDA approved DIANEAL PD-2 PD Solution, showing label designs, fill volumes, NDC codes, and key formulation information for 2500 mL containers.*

FDA Label Image

Dianeal Dhcp Letter 7 (Image 07)

Packaging labels for DIANEAL LOW CALCIUM WITH DEXTROSE Peritoneal Dialysis Solution, 2.5% Dextrose, 2500 mL bags from Baxter. The image shows three versions: an imported product from Guangzhou, China; a US FDA approved product; and another US FDA approved DIANEAL PD-2 solution. Labels include active ingredients such as sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and dextrose, dosage form as intraperitoneal injection, and the labeler Vantive US Healthcare LLC is referenced.*

FDA Label Image

Dianeal Dhcp Letter 8 (Image 08)

The image shows labels for Baxter's DIANEAL LOW CALCIUM WITH DEXTROSE peritoneal dialysis solution in 2500 mL containers. It includes an imported product label from Guangzhou, China, and two US FDA approved labels for DIANEAL Low Calcium PD Solution and DIANEAL PD-2 PD Solution. Each label details formulation strengths, warnings, usage, and container information, with 4.25% dextrose and low calcium specified. The labeler is Vantive US Healthcare LLC.*

FDA Label Image

Representative Dianeal Container Label (Image 09)

Label for Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose by Baxter. The injection solution contains specified amounts of dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. It is sterile, nonpyrogenic, and for intraperitoneal use only. The product is supplied in a 2500 mL UltraBag container by Baxter Healthcare (Guangzhou) Co Ltd, China, with storage and usage instructions. Label includes bilingual directions in English and Chinese.*

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Representative Dianeal Carton Label (Image 10)

Label for DIANEAL LOW CALCIUM WITH 1.5% DEXTROSE showing the concentration (1.5%), packaging type (ULTRABAG 2500mL x4), lot number, and expiration date. The label includes a large batch code and serial number details. The product is an intraperitoneal injection solution by Vantive US Healthcare LLC.*

FDA Label Image

Representative Dianeal Container Label (Image 11)

Packaging label for Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose by Baxter. The 3000 mL plastic container specifies active ingredients including dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. Instructions highlight use under physician direction, storage requirements, and sterility. Manufactured by Baxter Healthcare (Guangzhou) Co Ltd in China.*

FDA Label Image

Representative Dianeal Carton Label (Image 12)

Label showing DIANEAL LOW CALCIUM WITH 2.5% DEXTROSE in ULTRABAG format containing 2500 mL per bag, pack of four. The lot number and expiration date are printed as LOT G00000000 and EXP JAN 00, respectively. Large batch code 6AB9778E is visible.*

FDA Label Image

Representative Dianeal Container Label (Image 13)

The label for Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose by Baxter. The 2500 mL sterile, non-pyrogenic solution contains sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and dextrose with specified strengths per 100 mL. Directions indicate potassium chloride is to be added only under physician supervision. The container is a 3000 mL nominal size UltraBag plastic bag manufactured by Baxter Healthcare in Guangzhou, China.*

FDA Label Image

Representative Dianeal Carton Label (Image 14)

DIANEAL LOW CALCIUM WITH DEXTROSE 4.25% in an ultrabag container with a volume of 2500 mL. The label shows batch information with lot number and expiration date, indicating a multi-pack configuration of four bags. The label is designed for intraperitoneal injection use.*

* 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.