NDC 0002-7950 Etesevimab

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0002-7950
Proprietary Name:
Etesevimab
Product Type: [3]
Labeler Code:
0002
Marketing Category: [8]
EMERGENCY USE AUTHORIZATION -
Start Marketing Date: [9]
02-09-2021
End Marketing Date: [10]
02-25-2023
Listing Expiration Date: [11]
02-25-2023
Exclude Flag: [12]
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Product Details

What is NDC 0002-7950?

The NDC code 0002-7950 is assigned by the FDA to the product Etesevimab which is product labeled by Eli Lilly And Company. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 0002-7950-00 20 ml in 1 vial, single-dose , 0002-7950-01 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose. 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 Etesevimab?

None.

What are Etesevimab 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 Etesevimab UNII Codes?

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

Which are Etesevimab 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

Bamlanivimab and Etesevimab Injection


Bamlanivimab and etesevimab injection is used in certain non-hospitalized adults, children, and infants including newborns, 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). Bamlanivimab and etesevimab is also used to treat mild to moderate symptoms of COVID-19 in hospitalized children and infants less than 2 years of age, including newborns. Bamlanivimab and etesevimab are in a class called monoclonal antibodies. These medications work by blocking the action of a certain natural substance in the body to stop the spread of the virus.
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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 ("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".