1. Labeler Index
  2. Abbvie Inc.
  3. NDC Product Code: 0074-0522 Kaletra

NDC 0074-0522 Kaletra

Lopinavir And Ritonavir Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0074-0522?
    5. Kaletra Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code:
0074-0522
Proprietary Name:
Kaletra
Non-Proprietary Name: [1]
Lopinavir And Ritonavir
Substance Name: [2]
Lopinavir; Ritonavir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Abbvie Inc.
    Labeler Code:
    0074
    Product Label ID:
    8290add3-4449-4e58-6c97-8fe1eec972e3
    FDA Application Number: [6]
    NDA021906
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-18-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - PALE YELLOW)
    Shape:
    OVAL (C48345)
    Size(s):
    19 MM
    Imprint(s):
    A;KC
    Score:
    1

    Product Packages

    NDC Code 0074-0522-60

    Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 0074-0522?

    The NDC code 0074-0522 is assigned by the FDA to the product Kaletra which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Kaletra is lopinavir and ritonavir. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0074-0522-60 60 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 Kaletra?

    This combination product contains two medications: lopinavir and ritonavir. 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. Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. Ritonavir increases ("boosts") the levels of lopinavir. This helps lopinavir work better. Lopinavir/ritonavir is not a cure for HIV infection. 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.

    What are Kaletra 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.
    • LOPINAVIR 100 mg/1 - An HIV protease inhibitor used in a fixed-dose combination with RITONAVIR. It is also an inhibitor of CYTOCHROME P-450 CYP3A.
    • RITONAVIR 25 mg/1 - An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.

    Which are Kaletra UNII Codes?

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

    Which are Kaletra 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 Kaletra?

    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: 311369 - lopinavir 80 MG / ritonavir 20 MG in 1 mL Oral Solution
    • RxCUI: 311369 - lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution
    • RxCUI: 311369 - lopinavir 400 MG / ritonavir 100 MG per 5 ML Oral Solution
    • RxCUI: 311369 - lopinavir 80 MG / ritonavir 20 MG per 1 ML Oral Solution
    • RxCUI: 597730 - lopinavir 200 MG / ritonavir 50 MG Oral Tablet

    Which are the Pharmacologic Classes for Kaletra?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Lopinavir and Ritonavir


    The combination of lopinavir and ritonavir is used with other medications to treat human immunodeficiency virus (HIV) infection. Lopinavir and ritonavir are in a class of medications called protease inhibitors. They work by decreasing the amount of HIV in the blood. When lopinavir and ritonavir are taken together, ritonavir also helps to increase the amount of lopinavir in the body so that the medication will have a greater effect. Although lopinavir and ritonavir 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 life-style changes may decrease the risk of transmitting the HIV virus to other people.
    [Learn More]


    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


    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - 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.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [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".