NDC 68180-862 Azithromycin Dihydrate

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

Product Information

NDC Product Code:
68180-862
Proprietary Name:
Azithromycin Dihydrate
Non-Proprietary Name: [1]
Azithromycin Dihydrate
Substance Name: [2]
Azithromycin Dihydrate
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 Code:
    68180
    FDA Application Number: [6]
    ANDA065399
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-18-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    OVAL (C48345)
    Size(s):
    14 MM
    17 MM
    Imprint(s):
    LU;L04
    LU;L05
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 68180-862?

    The NDC code 68180-862 is assigned by the FDA to the product Azithromycin Dihydrate which is a human prescription drug product labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 68180-862-06 30 tablet in 1 container , 68180-862-11 1 blister pack in 1 carton / 3 tablet in 1 blister pack. 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 Azithromycin Dihydrate?

    Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae .Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis or Streptococcus pneumoniae .Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae .Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae .Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

    What are Azithromycin Dihydrate 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.
    • AZITHROMYCIN DIHYDRATE 500 mg/1 - A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

    Which are Azithromycin Dihydrate UNII Codes?

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

    • AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S)
    • AZITHROMYCIN ANHYDROUS (UNII: J2KLZ20U1M) (Active Moiety)

    Which are Azithromycin Dihydrate 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 Azithromycin Dihydrate?

    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 Azithromycin Dihydrate?

    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

    Azithromycin


    Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. Azithromycin also is used to treat or prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]. Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as azithromycin will not work for colds, flu, or other viral infections. Using 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".