NDC 0941-0413 Dianeal Pd-2 With Dextrose

Sodium Chloride,Sodium Lactate,Calcium Chloride,Magnesium Chloride And Dextrose Injection, - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0941-0413
Proprietary Name:
Dianeal Pd-2 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
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 Name: [5]
    Baxter Healthcare Corporation
    Labeler Code:
    0941
    FDA Application Number: [6]
    NDA017512
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-27-1978
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0941-0413-01

    Package Description: 6000 mL in 1 BAG

    NDC Code 0941-0413-04

    Package Description: 3000 mL in 1 BAG

    NDC Code 0941-0413-05

    Package Description: 1000 mL in 1 BAG

    NDC Code 0941-0413-06

    Package Description: 2000 mL in 1 BAG

    NDC Code 0941-0413-07

    Package Description: 5000 mL in 1 BAG

    Product Details

    What is NDC 0941-0413?

    The NDC code 0941-0413 is assigned by the FDA to the product Dianeal Pd-2 With Dextrose which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Dianeal Pd-2 With Dextrose is sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose. The product's dosage form is injection, solution and is administered via intraperitoneal form. The product is distributed in 5 packages with assigned NDC codes 0941-0413-01 6000 ml in 1 bag , 0941-0413-04 3000 ml in 1 bag , 0941-0413-05 1000 ml in 1 bag , 0941-0413-06 2000 ml in 1 bag , 0941-0413-07 5000 ml in 1 bag . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Dianeal Pd-2 With Dextrose?

    DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.

    What are Dianeal Pd-2 With Dextrose Active Ingredients?

    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 Dianeal Pd-2 With Dextrose UNII Codes?

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

    Which are Dianeal Pd-2 With Dextrose Inactive Ingredients 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 Dianeal Pd-2 With Dextrose?

    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: 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

    Which are the Pharmacologic Classes for Dianeal Pd-2 With Dextrose?

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".