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  4. NDC Product Code: 63481-529 Cortisporin Tc

NDC 63481-529 Cortisporin Tc

Colistin Sulfate,Neomycin Sulfate,Thonzonium Bromide And Hydrocortisone Acetate Suspension - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63481-529?
  4. Cortisporin Tc Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
63481-529
Proprietary Name:
Cortisporin Tc
Non-Proprietary Name: [1]
Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate
Substance Name: [2]
Colistin Sulfate; Hydrocortisone Acetate; Neomycin Sulfate; Thonzonium Bromide
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]
  • Auricular (otic) - Administration to or by way of the ear.
    • Labeler Name: [5]
    Endo Pharmaceuticals, Inc.
    Labeler Code:
    63481
    Product Label ID:
    9c6fc1c7-3350-42ae-b999-aca48e704bb1
    FDA Application Number: [6]
    NDA050356
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-03-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

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    Product Details

    What is NDC 63481-529?

    The NDC code 63481-529 is assigned by the FDA to the product Cortisporin Tc which is a human prescription drug product labeled by Endo Pharmaceuticals, Inc.. The generic name of Cortisporin Tc is colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate. The product's dosage form is suspension and is administered via auricular (otic) form. The product is distributed in a single package with assigned NDC code 63481-529-10 10 ml in 1 bottle, dropper . 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 Cortisporin Tc?

    Cortisporin®TC Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.

    What are Cortisporin Tc 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.
    • COLISTIN SULFATE 3 mg/mL - Cyclic polypeptide antibiotic from Bacillus colistinus. It is composed of Polymyxins E1 and E2 (or Colistins A, B, and C) which act as detergents on cell membranes. Colistin is less toxic than Polymyxin B, but otherwise similar; the methanesulfonate is used orally.
    • HYDROCORTISONE ACETATE 10 mg/mL
    • NEOMYCIN SULFATE 3.3 mg/mL - Aminoglycoside antibiotic complex produced by Streptomyces fradiae. It is composed of neomycins A, B, and C, and acts by inhibiting translation during protein synthesis.
    • THONZONIUM BROMIDE .5 mg/mL

    Which are Cortisporin Tc UNII Codes?

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

    Which are Cortisporin Tc 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 Cortisporin Tc?

    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: 854992 - colistin sulfate 3 MG / neomycin sulfate 3.3 MG / thonzonium bromide 0.5 MG / hydrocortisone acetate 10 MG per ML Otic Suspension
    • RxCUI: 854992 - colistin 3 MG/ML / hydrocortisone 10 MG/ML / neomycin 3.3 MG/ML / thonzonium bromide 0.5 MG/ML Otic Suspension
    • RxCUI: 854992 - colistin 0.3 % / hydrocortisone 1 % / neomycin 0.33 % / thonzonium bromide 0.05 % Otic Suspension
    • RxCUI: 854997 - Cortisporin-TC 3 MG / 3.3 MG / 0.5 MG / 10 MG per ML Otic Suspension
    • RxCUI: 854997 - colistin 3 MG/ML / hydrocortisone 10 MG/ML / neomycin 3.3 MG/ML / thonzonium bromide 0.5 MG/ML Otic Suspension [Cortisporin-TC]

    Which are the Pharmacologic Classes for Cortisporin Tc?

    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.

    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".