NDC 50090-0870 Truvada

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50090-0870
Proprietary Name:
Truvada
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
50090
Start Marketing Date: [9]
08-02-2004
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
GILEAD;701
Score:
1

Code Structure Chart

Product Details

What is NDC 50090-0870?

The NDC code 50090-0870 is assigned by the FDA to the product Truvada which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 50090-0870-0 30 tablet, film coated in 1 bottle, plastic , 50090-0870-2 5 tablet, film coated in 1 bottle , 50090-0870-3 3 tablet, film coated in 1 bottle . 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 Truvada?

This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also used to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. Also, it will not always prevent HIV infection. To help prevent becoming infected with HIV and to decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Which are Truvada UNII Codes?

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

Which are Truvada 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:

What is the NDC to RxNorm Crosswalk for Truvada?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (tenofovir disoproxil 245 MG) Oral Tablet
  • RxCUI: 639888 - Truvada 200 MG / 300 MG Oral Tablet
  • RxCUI: 639888 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada]
  • RxCUI: 639888 - Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (tenofovir disoproxil 245 MG) ) Oral Tablet

* Please review the disclaimer below.

Patient Education

Emtricitabine and Tenofovir


The combination of emtricitabine and tenofovir (Descovy, Truvada) is used along with other medications to treat HIV in adults and children who weigh at least 37 pounds (17 kg). Emtricitabine and tenofovir (Truvada) is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection) in high-risk adults and teenagers who weigh at least 77 pounds (35 kg). Emtricitabine and tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine and tenofovir will not cure HIV, these medications 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 getting or 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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HIV: PrEP and PEP


What are PrEP and PEP?

PrEP and PEP are medicines to prevent HIV. Each type is used in a different situation:

  • PrEP stands for pre-exposure prophylaxis. It is for people who don't already have HIV but are at risk of getting it. PrEP is medicine that can reduce this risk. It can either be a pill that you take every day or an injection that you get every two months. With PrEP, if you do get exposed to HIV, the medicine can stop HIV from taking hold and spreading throughout your body.
  • PEP stands for post-exposure prophylaxis. PEP is for people who have possibly been exposed to HIV. It is only for emergency situations. PEP must be started within 72 hours after a possible exposure to HIV.

PrEP (pre-exposure prophylaxis)

Who should consider taking PrEP?

PrEP can help protect you if you don't have HIV and any of these applies to you:

  • You have had anal or vaginal sex in the past 6 months and:
    • Have a sexual partner with HIV,
    • Have not consistently used a condom, OR
    • Have been diagnosed with a sexually transmitted disease in the past 6 months
  • You inject drugs and:
    • Share needles or other equipment to inject drugs OR
    • Have an injection partner with HIV
  • You have been prescribed PEP and:
    • Continue engaging in high-risk behaviors OR
    • Have used multiple courses of PEP

If you have a partner who is HIV-positive and are considering getting pregnant, talk to your health care provider about PrEP. Taking it may help protect you and your baby from getting HIV infection while you try to get pregnant, during pregnancy, or while breastfeeding.

How well does PrEP work?

PrEP is very effective when you take it consistently. It reduces the risk of getting HIV from sex by about 99%. In people who inject drugs, it reduces the risk of HIV by at least 74%. PrEP is much less effective if you do not take it consistently.

PrEP does not protect against other STDs, so you should still use latex condoms every time you have sex. If your or your partner is allergic to latex, you can use polyurethane condoms.

You must have an HIV test every 3 months while taking PrEP, so you'll have regular follow-up visits with your health care provider. If you are having trouble taking PrEP every day or if you want to stop taking PrEP, talk to your provider.

Does PrEP cause side effects?

Some people taking PrEP may have side effects, like nausea. The side effects are usually not serious and often get better over time. If you are taking PrEP, tell your provider if you have a side effect that bothers you or that does not go away.

PEP (post-exposure prophylaxis)

Who should consider taking PEP?

If you are HIV-negative and you think you may have been recently exposed to HIV, contact your health care provider immediately or go to an emergency room right away.

You may be prescribed PEP if you are HIV negative or don't know your HIV status, and in the last 72 hours you may have been exposed to HIV:

  • During sex, for example if a condom broke during sex with someone who could have HIV,
  • Through the sharing of needles or drug preparation equipment, OR
  • Through sexual assault

Your provider or emergency room doctor will help to decide whether PEP is right for you.

PEP may also be given to a health care worker after a possible exposure to HIV at work, for example, from a needlestick injury.

When should I start PEP and how long do I need to take it?

PEP must be started within 72 hours (3 days) after a possible exposure to HIV. The sooner you start it, the better; every hour counts.

You need to take the PEP medicines every day for 28 days. You will have to see your provider at certain times during and after taking the PEP, so you can have an HIV screening test and other testing.

Does PEP cause side effects?

Some people taking PEP may have side effects, like nausea. The side effects are usually not serious and often get better over time. If you are taking PEP, tell your provider if you have a side effect that bothers you or that does not go away.

PEP medicines may also interact with other medicines that a person is taking (called a drug interaction). So it's important to tell your provider about any other medicines that you take.

Can I take PEP every time I have unprotected sex?

PEP is only for emergency situations. It is not the right choice for people who may be exposed to HIV frequently - for example, if you often have sex without a condom with a partner who is HIV-positive. In that case, you should talk to your health care provider about whether PrEP (pre-exposure prophylaxis) would be right for you.


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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.

[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.

[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".