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  4. NDC Product Code: 65649-301 Xifaxan

NDC 65649-301 Xifaxan

Rifaximin Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65649-301?
  5. Xifaxan 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:
65649-301
Proprietary Name:
Xifaxan
Non-Proprietary Name: [1]
Rifaximin
Substance Name: [2]
Rifaximin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Salix Pharmaceuticals, Inc.
    Labeler Code:
    65649
    Product Label ID:
    c5e8e2fd-7087-4b78-9181-cc259c0be2f1
    FDA Application Number: [6]
    NDA021361
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-25-2004
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - PINK)
    Shape:
    ROUND (C48348)
    Size(s):
    10 MM
    Imprint(s):
    SX
    Score:
    1

    Product Packages

    NDC Code 65649-301-03

    Package Description: 30 TABLET in 1 BOTTLE

    Price per Unit: $10.10940 per EA

    Product Details

    What is NDC 65649-301?

    The NDC code 65649-301 is assigned by the FDA to the product Xifaxan which is a human prescription drug product labeled by Salix Pharmaceuticals, Inc.. The generic name of Xifaxan is rifaximin. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 65649-301-03 30 tablet 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 Xifaxan?

    This medication is used to treat diarrhea caused by the common bacteria known as E. coli ("traveler's diarrhea"). Rifaximin should not be used if you have a fever or bloody diarrhea. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Rifaximin is also used to treat irritable bowel syndrome with diarrhea. It is also used to prevent a brain problem caused by liver disease (hepatic encephalopathy). It may help you think more clearly.

    What are Xifaxan 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.
    • RIFAXIMIN 200 mg/1 - A synthetic rifamycin derivative and anti-bacterial agent that is used for the treatment of GASTROENTERITIS caused by ESCHERICHIA COLI INFECTIONS. It may also be used in the treatment of HEPATIC ENCEPHALOPATHY.

    Which are Xifaxan UNII Codes?

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

    Which are Xifaxan 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 Xifaxan?

    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:

    Which are the Pharmacologic Classes for Xifaxan?

    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

    Rifaximin


    Rifaximin 200-mg tablets are used to treat traveler's diarrhea caused by certain bacteria in adults and children at least 12 years of age. Rifaximin 550-mg tablets are used to prevent episodes of hepatic encephalopathy (changes in thinking, behavior, and personality caused by a build-up of toxins in the brain in people who have liver disease) in adults who have liver disease and to treat irritable bowel syndrome (with diarrhea) in adults. Rifaximin is in a class of medications called antibiotics. Rifaximin treats traveler's diarrhea and irritable bowel syndrome by stopping the growth of the bacteria that cause diarrhea. Rifaximin treats hepatic encephalopathy by stopping the growth of bacteria that produce toxins and that may worsen liver disease. Rifaximin will not work to treat traveler's diarrhea that is bloody or occurs with fever. Antibiotics such as rifaximin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
    [Learn More]


    Antibiotics


    What are antibiotics?

    Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply.

    Antibiotics can be taken in different ways:

    • Orally (by mouth). This could be pills, capsules, or liquids.
    • Topically. This might be a cream, spray, or ointment that you put on your skin. It could also be eye ointment, eye drops, or ear drops.
    • Through an injection or intravenously (IV). This is usually for more serious infections.

    What do antibiotics treat?

    Antibiotics only treat certain bacterial infections, such as strep throat, urinary tract infections, and E. coli.

    You may not need to take antibiotics for some bacterial infections. For example, you might not need them for many sinus infections or some ear infections. Taking antibiotics when they're not needed won't help you, and they can have side effects. Your health care provider can decide the best treatment for you when you're sick. Don't ask your provider to prescribe an antibiotic for you.

    Do antibiotics treat viral infections?

    Antibiotics do not work on viral infections. For example, you shouldn't take antibiotics for:

    What are the side effects of antibiotics?

    The side effects of antibiotics range from minor to very severe. Some of the common side effects include:

    More serious side effects can include:

    Call your health care provider if you develop any side effects while taking your antibiotic.

    Why is it important to take antibiotics only when they're needed?

    You should only take antibiotics when they are needed because they can cause side effects and can contribute to antibiotic resistance. Antibiotic resistance happens when the bacteria change and become able to resist the effects of an antibiotic. This means that the bacteria continue to grow.

    How do I use antibiotics correctly?

    When you take antibiotics, it is important that you take them responsibly:

    • Always follow the directions carefully. Finish your medicine even if you feel better. If you stop taking them too soon, some bacteria may survive and re-infect you.
    • Don't save your antibiotics for later.
    • Don't share your antibiotic with others.
    • Don't take antibiotics prescribed for someone else. This may delay the best treatment for you, make you even sicker, or cause side effects.

    Centers for Disease Control and Prevention


    [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".