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  4. NDC Product Code: 67457-978 Aloprim

NDC 67457-978 Aloprim

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 67457-978?
  4. Aloprim Uses
  5. Active Ingredients UNII Codes
  6. 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) 67457-978 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:
67457-978
Proprietary Name:
Aloprim
Product Type: [3]
Labeler Name: [5]
Mylan Institutional Llc
Labeler Code:
67457
Product Label ID:
018525b1-e37d-4ff2-9dc3-36b3d90ac3e0
HCPCS Code:
J0206 - Inj allopurinol sodium 1 mg
FDA Application Number: [6]
NDA020298
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
11-18-2020
End Marketing Date: [10]
11-30-2025
Listing Expiration Date: [11]
11-30-2025
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 67457-978?

The NDC code 67457-978 is assigned by the FDA to the product Aloprim which is product labeled by Mylan Institutional Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 67457-978-50 1 vial, glass in 1 carton / 25 ml in 1 vial, glass. 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 Aloprim?

ALOPRIM (allopurinol sodium) for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.

Which are Aloprim UNII Codes?

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

* Please review the disclaimer below.

Patient Education

Allopurinol Injection


Allopurinol injection is used to treat high levels of uric acid (a natural substance that builds up in the blood as tumors break down) in people with certain types of cancer who are being treated with chemotherapy medications who cannot take oral allopurinol. Allopurinol is in a class of medications called xanthine oxidase inhibitors. It works by reducing the production of uric acid in the body.
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* 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".