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NDC 50090-0247 Neomycin And Polymyxin B Sulfates And Gramicidin

Neomycin Sulfate,Polymyxin B Sulfate And Gramicidin Solution/ Drops Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50090-0247?
  4. Neomycin And Polymyxin B Sulfates And Gramicidin 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:
50090-0247
Proprietary Name:
Neomycin And Polymyxin B Sulfates And Gramicidin
Non-Proprietary Name: [1]
Neomycin Sulfate, Polymyxin B Sulfate And Gramicidin
Substance Name: [2]
Gramicidin; Neomycin Sulfate; Polymyxin B Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    A-s Medication Solutions
    Labeler Code:
    50090
    Product Label ID:
    9691178e-5323-40ce-a8b3-f79e88f02797
    FDA Application Number: [6]
    ANDA064047
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-31-1996
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 50090-0247-0

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

    Product Details

    What is NDC 50090-0247?

    The NDC code 50090-0247 is assigned by the FDA to the product Neomycin And Polymyxin B Sulfates And Gramicidin which is a human prescription drug product labeled by A-s Medication Solutions. The generic name of Neomycin And Polymyxin B Sulfates And Gramicidin is neomycin sulfate, polymyxin b sulfate and gramicidin. The product's dosage form is solution/ drops and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 50090-0247-0 1 bottle, dropper in 1 carton / 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 Neomycin And Polymyxin B Sulfates And Gramicidin?

    Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

    What are Neomycin And Polymyxin B Sulfates And Gramicidin 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.
    • GRAMICIDIN .025 mg/mL - A group of peptide antibiotics from BACILLUS brevis. Gramicidin C or S is a cyclic, ten-amino acid polypeptide and gramicidins A, B, D are linear. Gramicidin is one of the two principal components of TYROTHRICIN.
    • NEOMYCIN SULFATE 1.75 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.
    • 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.

    Which are Neomycin And Polymyxin B Sulfates And Gramicidin UNII Codes?

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

    Which are Neomycin And Polymyxin B Sulfates And Gramicidin 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 Neomycin And Polymyxin B Sulfates And Gramicidin?

    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: 310594 - gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic Solution
    • RxCUI: 310594 - gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Solution
    • RxCUI: 310594 - gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic Solution

    Which are the Pharmacologic Classes for Neomycin And Polymyxin B Sulfates And Gramicidin?

    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.

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    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".