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  4. NDC Product Code: 58468-0127 Hectorol

NDC 58468-0127 Hectorol

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58468-0127?
  4. Hectorol Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 58468-0127 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
58468-0127
Proprietary Name:
Hectorol
Product Type: [3]
Labeler Name: [5]
Genzyme Corporation
Labeler Code:
58468
Product Label ID:
7efc3d9c-12f5-43f6-9a22-88d66cbe6f62
HCPCS Code:
J1270 - Injection, doxercalciferol
FDA Application Number: [6]
NDA021027
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
12-08-2008
End Marketing Date: [10]
09-30-2024
Listing Expiration Date: [11]
09-30-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 58468-0127?

The NDC code 58468-0127 is assigned by the FDA to the product Hectorol which is product labeled by Genzyme Corporation. The product's dosage form is . The product is distributed in a single package with assigned NDC code 58468-0127-1 50 vial, multi-dose in 1 box / 2 ml in 1 vial, multi-dose (58468-0127-0). 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 Hectorol?

This medication is used to treat people with serious kidney disease on dialysis who have high levels of a certain substance (parathyroid hormone-PTH), which your body normally makes. High PTH levels affect the balance of other minerals in your body (calcium and phosphorus) and may cause weak bones. Doxercalciferol is a form of vitamin D. It works by decreasing PTH levels and increasing calcium/phosphorus levels in the body.

Which are Hectorol UNII Codes?

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

Which are Hectorol 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:

* Please review the disclaimer below.

Patient Education

Doxercalciferol Injection


Doxercalciferol injection is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood] in people receiving dialysis (medical treatment to clean the blood when the kidneys are not working properly). Doxercalciferol injection is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements and regulating the body's production of parathyroid hormone.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[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.

[10] 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.

[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, 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".