Dianeal Low Calcium With Dextrose Injection, Solution
NDC Package 0941-0484-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dianeal Low Calcium With Dextrose (sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose) injection is dIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. This formulation utilizes a injection, solution delivery system. Marketed by Vantive Us Healthcare Llc, this product is identified by NDC 0941-0484 and is authorized under FDA application NDA017512.

Identification & Billing

NDC Package Code
0941-0484-01
Package Description
5000 mL in 1 BAG
Product Code
0941-0484
11-Digit Billing Format
00941048401
RxNorm Crosswalk
  • RxCUI: 799999 - calcium chloride 0.00014 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution
  • RxCUI: 799999 - Calcium Chloride 0.00014 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution
  • RxCUI: 800003 - calcium chloride 0.00014 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/4.25]
  • RxCUI: 800003 - Calcium Chloride 0.00014 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/4.25]
  • RxCUI: 800003 - Dianeal PD-2/4.25 2500 ML Intraperitoneal Solution

Clinical Specifications

Proprietary Name
Dianeal Low Calcium With Dextrose
Non-Proprietary Name
Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
Substance Name
Calcium Chloride; Dextrose Monohydrate; Magnesium Chloride; Sodium Chloride; Sodium Lactate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intraperitoneal - Administration within the peritoneal cavity.
Active Ingredient(s)
Pharmacologic Class
Usage Information
DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.

Regulatory & Marketing

Labeler Name
Vantive Us Healthcare Llc
Product Type
Human Prescription Drug
FDA Application #
NDA017512
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-27-1978
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0941-0484-01 identifies a specific commercial package of 5000 ml in 1 bag of Dianeal Low Calcium With Dextrose, a human prescription drug labeled by Vantive Us Healthcare Llc. This injection, solution is formulated for intraperitoneal use and contains calcium chloride; dextrose monohydrate; magnesium chloride; sodium chloride; sodium lactate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Vantive Us Healthcare Llc on September 27, 1978. The current certification is valid through December 31, 2027.

How is this Vantive Us Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00941048401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0941-0484-01
11-Digit CMS (5-4-2)
00941-0484-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.