NDC 67457-921 Sulfamethoxazole And Trimethoprim

Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
67457-921
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:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Mylan Institutional Llc
    Labeler Code:
    67457
    FDA Application Number: [6]
    ANDA206607
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    10-12-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 67457-921-05

    Package Description: 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00)

    Product Details

    What is NDC 67457-921?

    The NDC code 67457-921 is assigned by the FDA to the product Sulfamethoxazole And Trimethoprim which is a human prescription drug product labeled by Mylan Institutional Llc. The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 67457-921-05 10 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (67457-921-00). 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?

    Sulfamethoxazole and trimethoprim injection is contraindicated in the following: •Known hypersensitivity to trimethoprim or sulfonamides [see Warnings and Precautions (5.2)] •History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides [see Warnings and Precautions (5.3)] •Patients with documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.10)] •Pediatric patients less than two months of age [see Use in Specific Populations (8.4)] •Marked hepatic damage [see Warnings and Precautions (5.10, 5.13)] •Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.10, 5.13)]•Concomitant administration with dofetilide2,3[see Drug Interactions (7)]

    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 80 mg/mL - 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 16 mg/mL - 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: 1809083 - sulfamethoxazole 400 MG / trimethoprim 80 MG in 5 ML Injection
    • RxCUI: 1809083 - 5 ML sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injection
    • RxCUI: 1809083 - 5 ML SMX 80 MG/ML / TMP 16 MG/ML Injection
    • RxCUI: 1809083 - sulfamethoxazole 400 MG / trimethoprim 80 MG per 5 ML Injection
    • RxCUI: 313137 - sulfamethoxazole 80 MG / trimethoprim 16 MG in 1 ML Injectable Solution

    Which are the Pharmacologic Classes for Sulfamethoxazole And Trimethoprim?

    * Please review the disclaimer below.

    Patient Education

    Co-trimoxazole Injection


    Co-trimoxazole injection is used to treat certain infections that are caused by bacteria such as infection of the intestine, lungs (pneumonia), and urinary tract. Co-trimoxazole should not be used in children younger than 2 months of age. Co-trimoxazole injection is in a class of medications called sulfonamides. It works by killing bacteria. Antibiotics such as co-trimoxazole injection 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]


    * 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".