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NDC 24208-358 Zylet

Loteprednol Etabonate And Tobramycin Suspension/ Drops Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 24208-358?
  4. Zylet Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes
  9. Patient Education

Product Information

NDC Product Code:
24208-358
Proprietary Name:
Zylet
Non-Proprietary Name: [1]
Loteprednol Etabonate And Tobramycin
Substance Name: [2]
Loteprednol Etabonate; Tobramycin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    Bausch & Lomb Incorporated
    Labeler Code:
    24208
    Product Label ID:
    3dd9b060-5355-404d-bdf1-09ee8b52a9f5
    FDA Application Number: [6]
    NDA050804
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    12-14-2004
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 24208-358?

    The NDC code 24208-358 is assigned by the FDA to the product Zylet which is a human prescription drug product labeled by Bausch & Lomb Incorporated. The generic name of Zylet is loteprednol etabonate and tobramycin. The product's dosage form is suspension/ drops and is administered via ophthalmic form. The product is distributed in 3 packages with assigned NDC codes 24208-358-01 1 bottle, dropper in 1 carton / 1 ml in 1 bottle, dropper, 24208-358-05 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper, 24208-358-10 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 Zylet?

    This medication is used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections. This product contains tobramycin, an antibiotic that works by stopping the growth of bacteria. It also contains loteprednol, an anti-inflammatory corticosteroid that works by reducing swelling, redness, and itching. This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections and may worsen them (e.g., infections caused by viruses, fungi, mycobacteria). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

    What are Zylet 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.
    • LOTEPREDNOL ETABONATE 5 mg/mL - An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions.
    • TOBRAMYCIN 3 mg/mL - An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.

    Which are Zylet UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Zylet?

    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: 545255 - loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension
    • RxCUI: 545255 - loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension
    • RxCUI: 545259 - Zylet 0.5 % / 0.3 % Ophthalmic Suspension
    • RxCUI: 545259 - loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Zylet]
    • RxCUI: 545259 - Zylet (loteprednol etabonate 0.5 % / tobramycin 0.3 % ) Ophthalmic Suspension

    Which are the Pharmacologic Classes for Zylet?

    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.

    Patient Education

    Loteprednol Ophthalmic


    Ophthalmic loteprednol products are used to treat different eye conditions: Loteprednol (Inveltys, Lotemax, Lotemax SM) is used to treat swelling and pain after cataract surgery (procedure to treat clouding of the lens in the eye). Loteprednol (Alrex) is used to reduce eye redness, itching, and swelling caused by seasonal allergies. Loteprednol (Lotemax) is used to reduce eye swelling caused by allergies, certain eye infections, ocular rosacea (condition that can cause swelling, redness, and itching of the eye), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past and can affect the eyes), and other eye conditions. Loteprednol (Eysuvis) is used to treat dry eye disease (an eye disorder in which tears do not provide sufficient eye lubrication). Loteprednol is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling, itching, and pain.
    [Learn More]


    Tobramycin Ophthalmic


    Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works 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".