NDC 0069-0345 Paxlovid

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Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0069-0345
Proprietary Name:
Paxlovid
Product Type: [3]
Labeler Code:
0069
Marketing Category: [8]
EMERGENCY USE AUTHORIZATION -
Start Marketing Date: [9]
04-18-2022
End Marketing Date: [10]
03-08-2024
Listing Expiration Date: [11]
03-08-2024
Exclude Flag: [12]
D
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Patient Education

Nirmatrelvir and Ritonavir


The combination of nirmatrelvir and ritonavir is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) who have mild to moderate symptoms and are at risk of severe disease that could result in hospitalization or death. Nirmatrelvir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body. Ritonavir is in a class of medications called pharmacokinetic boosters. It works by increasing the amount of nirmatrelvir available in the body so that the medication will have a greater effect.
[Learn More]


Ritonavir


Ritonavir is used along with other medications to treat human immunodeficiency virus (HIV) infection. Ritonavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Although ritonavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people.
[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 ("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".