Ful-glo
Fluorescein Sodium
Akorn
Human Prescription Drug
NDC 17478-404Ful-glo also known as Fluorescein Sodium is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Ful-glo is 17478-404. This drug is available in dosage form of Strip. The names of the active, medicinal ingredients in Ful-glo drug includes Fluorescein Sodium - 1 mg/1 . The currest status of Ful-glo drug is Active.
Drug Information:
| Drug NDC: | 17478-404 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ful-glo |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Fluorescein Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Akorn |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Strip |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FLUORESCEIN SODIUM - 1 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jun, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Akorn
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 93X55PE38X
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Diagnostic Dye [EPC]
Dyes [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 17478-404-01 | 100 APPLICATOR in 1 CARTON (17478-404-01) / 1 STRIP in 1 APPLICATOR | 01 Jun, 2004 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Ful-glo fluorescein sodium fluorescein sodium fluorescein
Indications and Usage:
Indications: for staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.
Dosage and Administration:
Directions for use: to ensure full fluorescence and patient comfort, the ful-glo impregnated tip should be moistened before application. one or two drops of sterile irrigation solution should be used for this purpose. touch conjunctiva or fornix as required with moistened tip. it is recommended that the patient blink several times after application. note: contents may not be sterile if individual strip package has been damaged or previously opened. store below 30°c.
How Supplied:
How supplied: dispenser carton containing 100 sterile strips. 100 sterile strips msn 015-084 fgblc rev. 11/10 manufactured for: akorn, inc. lake forest, il 60045
Information for Patients:
Instructions for opening sterile strips: 1. separate tab ends. pull apart slowly until white handle visible. remove from envelope. fig. 1 or, for a convenient handle protector- 2. grasp envelope firmly with two hands as shown in fig. 2. tear down the middle of envelope to strip. fig. 2 hold the handle end of the strip firmly in the right hand as shown in fig 3. hold left edge of paper envelope so that tip is not held between the fingers. fig. 3 snap the left portion off quickly. strip is ready to use with a convenient handle protector. fig. 4 figure 1 figure 2 figure 3 figure 4
Package Label Principal Display Panel:
Principal display panel text for container label: ndc 17478-404-01 one sterile strip ful-glo® fluorescein sodium sterile ophthalmic strips 1 mg contents may not be sterile if this package has been damaged or previously opened. see box for complete information. principal display panel text for container label
Principal display panel text for carton label: ndc 17478-404-01 ful-glo® fluorescein sodium ophthalmic strips, usp 1 mg diagnostic agent for professional use only 100 sterile strips akorn logo principal display panel text for carton label