NDC 70954-258 Sulfamethoxazole And Trimethoprim

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

Product Information

NDC Product Code:
70954-258
Proprietary Name:
Sulfamethoxazole And Trimethoprim
Non-Proprietary Name: [1]
Sulfamethoxazole And Trimethoprim
Substance Name: [2]
Sulfamethoxazole; Trimethoprim
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Ani Pharmaceuticals, Inc.
    Labeler Code:
    70954
    FDA Application Number: [6]
    ANDA214330
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    02-08-2022
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Flavor(s):
    CHERRY (C73375)

    Product Packages

    NDC Code 70954-258-10

    Package Description: 473 mL in 1 BOTTLE

    Price per Unit: $0.06097 per ML

    Product Details

    What is NDC 70954-258?

    The NDC code 70954-258 is assigned by the FDA to the product Sulfamethoxazole And Trimethoprim which is a human prescription drug product labeled by Ani Pharmaceuticals, Inc.. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 70954-258-10 473 ml 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 Sulfamethoxazole And Trimethoprim?

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim pediatric suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim pediatric suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.Pneumocystisjirovecii Pneumonia: For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.  jirovecii pneumonia.Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.

    What are Sulfamethoxazole And Trimethoprim 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.
    • SULFAMETHOXAZOLE 200 mg/5mL - A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208)
    • TRIMETHOPRIM 40 mg/5mL - A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.

    Which are Sulfamethoxazole And Trimethoprim UNII Codes?

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

    Which are Sulfamethoxazole And Trimethoprim 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 Sulfamethoxazole And Trimethoprim?

    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: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension
    • RxCUI: 313134 - sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension
    • RxCUI: 313134 - SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension
    • RxCUI: 313134 - sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension
    • RxCUI: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension

    Which are the Pharmacologic Classes for Sulfamethoxazole And Trimethoprim?

    * Please review the disclaimer below.

    Patient Education

    Co-trimoxazole


    Co-trimoxazole is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the urinary tract, ears, and intestines. It also is used to treat 'travelers' diarrhea. Co-trimoxazole is a combination of trimethoprim and sulfamethoxazole and is in a class of medications called sulfonamides. It works by stopping the growth of bacteria. Antibiotics will not kill viruses that can cause colds, flu, or other viral infections.
    [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".