NDC 0074-6633 Norvir

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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) 0074-6633 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:
0074-6633
Proprietary Name:
Norvir
Product Type: [3]
Labeler Name: [5]
Labeler Code:
0074
FDA Application Number: [6]
NDA020945
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-06-2010
End Marketing Date: [10]
05-21-2016
Listing Expiration Date: [11]
05-21-2016
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 who have mild to moderate symptoms and are at risk of severe disease that could result in hospitalization or death. The FDA has also issued an emergency use authorization (EUA) authorizing use of nirmatrelvir and ritonavir to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in children 12 years of age and older who weigh at least 88 pounds (40 kg). 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.
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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.
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HIV Medicines


What is HIV?

HIV stands for human immunodeficiency virus. It harms your immune system by destroying CD4 cells. These are a type of white blood cells that fight infection. The loss of these cells makes it hard for your body to fight off infections and certain HIV-related cancers.

Without treatment, HIV can gradually destroy the immune system and advance to AIDS. AIDS stands for acquired immunodeficiency syndrome. It is the final stage of infection with HIV. Not everyone with HIV develops AIDS.

What is antiretroviral therapy (ART)?

The treatment of HIV with medicines is called antiretroviral therapy (ART). It involves taking a combination of medicines every day. ART is recommended for everyone who has HIV. The medicines do not cure HIV infection, but help people with HIV live longer, healthier lives. They also reduce the risk of spreading the virus to others.

How do HIV medicines work?

HIV medicines reduce the amount of HIV (viral load) in your body, which helps by:

  • Giving your immune system a chance to recover. Even though there is still some HIV in your body, your immune system should be strong enough to fight off infections and certain HIV-related cancers.
  • Reducing the risk that you will spread HIV to others.

What are the types of HIV medicines?

There are many different types (called classes) of HIV medicines. Some work by blocking or changing enzymes that HIV needs to make copies of itself. This prevents HIV from copying itself, which reduces the amount of HIV in the body. Several types of medicines do this:

  • Nucleoside reverse transcriptase inhibitors (NRTIs) block an enzyme called reverse transcriptase
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs) bind to and later change reverse transcriptase
  • Integrase inhibitors, also called integrase strand transfer inhibitors (INSTIs), block an enzyme called integrase
  • Protease inhibitors (PIs) block an enzyme called protease

Some types of HIV medicines interfere with HIV's ability to infect CD4 immune system cells:

  • Fusion inhibitors block HIV from entering the cells
  • CCR5 antagonists and post-attachment inhibitors block different molecules on the CD4 cells. To infect a cell, HIV has to bind to two types of molecules on the cell's surface. Blocking either of these molecules prevents HIV from entering the cells.
  • Attachment inhibitors bind to a specific protein on the outer surface of HIV. This prevents HIV from entering the cell.

Pharmacokinetic enhancers are another type of medicine. They are sometimes taken along with certain other HIV medicines. Pharmacokinetic enhancers increase the effectiveness of the other medicine. They work by slowing the breakdown of the other medicine. This allows that medicine to stay in the body longer at a higher concentration.

There are also multidrug combinations, which include a combination of two or more different types of HIV medicines.

When do I need to start taking HIV medicines?

It's important to start taking HIV medicines as soon as possible after your diagnosis, especially if you:

  • Are pregnant
  • Have AIDS
  • Have certain HIV-related illnesses and infections
  • Have an early HIV infection (the first 6 months after infection with HIV)

What else do I need to know about taking HIV medicines?

You and your health care provider will work together to come up with a personal treatment plan. This plan will be based on many factors, including:

  • The possible side effects of HIV medicines
  • Potential drug interactions with any other medicines you take
  • How many medicines you will need to take every day
  • Any other health problems you may have

It's important to take your medicines every day, according to the instructions from your provider. If you miss doses or don't follow a regular schedule, your treatment may not work, and the HIV virus may become resistant to the medicines.

HIV medicines can cause side effects. Most of these side effects are manageable, but a few can be serious. Tell your provider about any side effects that you are having. Don't stop taking your medicine without first talking to your provider. There may be steps you can take to help manage the side effects. In some cases, your provider may decide to change your medicines.

What are HIV PrEP and PEP medicines?

HIV medicines are not just used for treatment. Some people take them to prevent HIV. PrEP (pre-exposure prophylaxis) is for people who don't already have HIV but are at very high risk of getting it. PEP (post-exposure prophylaxis) is for people who have possibly been exposed to HIV.

NIH: Office of AIDS Research


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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.

[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".