Dianeal Low Calcium With Dextrose Injection, Solution
NDC 0941-0727

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0941-0727?
  4. Active Ingredients
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

Dianeal Low Calcium With Dextrose (sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose) is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Vantive Us Healthcare Llc. This medication is typically used as a blood coagulation factor [epc]. It is supplied as a injection, solution for intraperitoneal administration. This product entry covers the primary NDC 0941-0727 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0941-0727
Proprietary Name:
Dianeal Low Calcium With Dextrose
Non-Proprietary Name: [1]
Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
Substance Name: [2]
Calcium Chloride; Dextrose Monohydrate; Magnesium Chloride; Sodium Chloride; Sodium Lactate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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(s): [4]
Intraperitoneal - Administration within the peritoneal cavity.

Labeler & Regulatory Data

Labeler Name: [5]
Vantive Us Healthcare Llc
Labeler Code:
0941
Product Label ID:
b79ef556-37b3-4fd0-8589-c633033be9df
Marketing Category: [8]
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

Marketing Timeline

Start Marketing Date: [9]
10-29-2024
End Marketing Date: [10]
01-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0941-0727?

The NDC code 0941-0727 is assigned by the FDA to the product Dianeal Low Calcium With Dextrose. It is commonly known by its generic name, sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose. This pharmaceutical product is labeled by Vantive Us Healthcare Llc and is currently categorized as listed product. The medication is a injection, solution administered via intraperitoneal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0941-0727-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 800066 - calcium chloride 0.000996 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: 800066 - Calcium Chloride 0.000996 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: 800074 - calcium chloride 0.000996 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 Low Calcium 4.25]
  • RxCUI: 800074 - Calcium Chloride 0.000996 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 Low Calcium 4.25]
  • RxCUI: 800074 - Dianeal Low Calcium 4.25 % Intraperitoneal Solution

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".