NDC 68071-4103 Polymyxin B Sulfate And Trimethoprim

Solution Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68071-4103
Proprietary Name:
Polymyxin B Sulfate And Trimethoprim
Non-Proprietary Name: [1]
Polymyxin B Sulfate And Trimethoprim
Substance Name: [2]
Polymyxin B Sulfate; Trimethoprim Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
  • Labeler Name: [5]
    Nucare Pharmaceuticals,inc.
    Labeler Code:
    68071
    FDA Application Number: [6]
    ANDA064211
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    04-16-1998
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 68071-4103-5

    Package Description: 10 mL in 1 BOX

    Product Details

    What is NDC 68071-4103?

    The NDC code 68071-4103 is assigned by the FDA to the product Polymyxin B Sulfate And Trimethoprim which is a human prescription drug product labeled by Nucare Pharmaceuticals,inc.. The product's dosage form is solution and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 68071-4103-5 10 ml in 1 box . 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 Polymyxin B Sulfate And Trimethoprim?

    Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.* *Efficacy for this organism in this organ system was studied in fewer than 10 infections.

    What are Polymyxin B Sulfate 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.
    • POLYMYXIN B SULFATE 10000 [USP'U]/mL - A mixture of polymyxins B1 and B2, obtained from BACILLUS POLYMYXA strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for treatment of infections with gram-negative bacteria, but may be neurotoxic and nephrotoxic.
    • TRIMETHOPRIM SULFATE 1 mg/mL

    Which are Polymyxin B Sulfate And Trimethoprim UNII Codes?

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

    Which are Polymyxin B Sulfate 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 Polymyxin B Sulfate 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: 244967 - polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution
    • RxCUI: 244967 - polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution
    • RxCUI: 244967 - polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution
    • RxCUI: 244967 - polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution
    • RxCUI: 244967 - Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution

    Which are the Pharmacologic Classes for Polymyxin B Sulfate And Trimethoprim?

    * Please review the disclaimer below.

    Patient Education

    Polymyxin B and Trimethoprim Ophthalmic


    Polymyxin B and trimethoprim ophthalmic combination is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of the membrane that covers the outside of the eyeball and the inside of the eyelid) or blepharoconjunctivitis (infection of the membrane that covers the outside of the eyeball and the inside and outer parts of the eyelid). Polymyxin B and trimethoprim are in a class of medications called antibiotics. They work by killing bacteria that cause infections.
    [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".