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  4. NDC Product Code: 51801-009 Glostrips

NDC 51801-009 Glostrips

Fluorescein Sodium Strip Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51801-009?
  5. Glostrips Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
51801-009
Proprietary Name:
Glostrips
Non-Proprietary Name: [1]
Fluorescein Sodium
Substance Name: [2]
Fluorescein Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Strip - A long narrow piece of material.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    Nomax Inc.
    Labeler Code:
    51801
    Product Label ID:
    d06a4432-c76c-4e2a-abec-6bc5b4e82d51
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    07-30-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - PAPER IS WHITE AND TIP IS ORANGE)
    Shape:
    RECTANGLE (C48347)
    Size(s):
    52 MM

    Product Packages

    NDC Code 51801-009-40

    Package Description: 100 POUCH in 1 CARTON / 1 STRIP in 1 POUCH

    NDC Code 51801-009-50

    Package Description: 300 POUCH in 1 CARTON / 1 STRIP in 1 POUCH

    Product Details

    What is NDC 51801-009?

    The NDC code 51801-009 is assigned by the FDA to the product Glostrips which is a human prescription drug product labeled by Nomax Inc.. The generic name of Glostrips is fluorescein sodium. The product's dosage form is strip and is administered via ophthalmic form. The product is distributed in 2 packages with assigned NDC codes 51801-009-40 100 pouch in 1 carton / 1 strip in 1 pouch, 51801-009-50 300 pouch in 1 carton / 1 strip in 1 pouch. 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 Glostrips?

    For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.

    What are Glostrips 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.

    Which are Glostrips UNII Codes?

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

    Which are the Pharmacologic Classes for Glostrips?

    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.

    [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".