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  4. NDC Product Code: 61755-039 Regen-cov

NDC 61755-039 Regen-cov

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 61755-039?
  4. Regen-cov Uses
  5. 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) 61755-039 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:
61755-039
Proprietary Name:
Regen-cov
Product Type: [3]
Labeler Name: [5]
Regeneron Pharmaceuticals, Inc.
Labeler Code:
61755
Product Label ID:
f5bf7a31-7e17-4a94-805c-d231ea458fb0
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
06-03-2021
End Marketing Date: [10]
12-13-2024
Listing Expiration Date: [11]
12-13-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Patient Education

Casirivimab and Imdevimab Injection


Casirivimab and imdevimab injection is used in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have certain medical conditions that make them at higher risk for developing severe COVID-19 symptoms, including hospitalization or death: to treat mild to moderate symptoms of COVID-19. to prevent COVID-19 in those who are not fully vaccinated against COVID-19 or who are vaccinated, but have a weakened immune system, or are taking a medication that affects the immune system and who have had close contact or are at high risk of close contact to someone who is infected with the SARS-CoV-2 virus (for example, nursing homes, prisons). Casirivimab and imdevimab are in a class of medications called monoclonal antibodies. They work by blocking the action of a certain natural substance in the body in order to stop the spread of the virus.
[Learn More]


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Product Footnotes

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

[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".