Extraneal
NDC 0941-0717
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Extraneal is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Vantive Us Healthcare Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 0941-0717 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0941-0717
Proprietary Name:
Extraneal
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0941
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing Timeline
Start Marketing Date: [9]
10-21-2024
End Marketing Date: [10]
07-31-2026
Listing Expiration Date: [11]
07-31-2026
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 0941-0717?
The NDC code 0941-0717 is assigned by the FDA to the product Extraneal. This pharmaceutical product is labeled by Vantive Us Healthcare Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0941-0717-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ICODEXTRIN (UNII: 2NX48Z0A9G)
- ICODEXTRIN (UNII: 2NX48Z0A9G) (Active Moiety)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)
- CHLORIDE ION (UNII: Q32ZN48698) (Active Moiety)
- SODIUM LACTATE (UNII: TU7HW0W0QT)
- LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (Active Moiety)
- CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
- CALCIUM CATION (UNII: 2M83C4R6ZB) (Active Moiety)
- MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
- MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)
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: 1100742 - calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution
- RxCUI: 1100742 - Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution
- RxCUI: 1100746 - Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable Solution
- RxCUI: 1100746 - calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal]
- RxCUI: 1100746 - Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal]
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Product & Regulatory Definitions
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 Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".