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  4. NDC Product Code: 17478-716 Apraclonidine Ophthalmic

NDC 17478-716 Apraclonidine Ophthalmic

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 17478-716?
  4. Apraclonidine Ophthalmic Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
17478-716
Proprietary Name:
Apraclonidine Ophthalmic
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Akorn
Labeler Code:
17478
Product Label ID:
dc7d3a9f-c0b9-411c-9c62-0a14f1718b00
Start Marketing Date: [9]
08-12-2009
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
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Product Details

What is NDC 17478-716?

The NDC code 17478-716 is assigned by the FDA to the product Apraclonidine Ophthalmic which is product labeled by Akorn. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 17478-716-10 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper, 17478-716-11 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 Apraclonidine Ophthalmic?

Apraclonidine Ophthalmic Solution, USP 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction. Patients on maximally tolerated medical therapy who are treated with Apraclonidine Ophthalmic Solution, USP 0.5% as base to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly. The addition of Apraclonidine Ophthalmic Solution, USP 0.5% as base to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because Apraclonidine Ophthalmic Solution, USP 0.5% as base is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of Apraclonidine Ophthalmic Solution, USP 0.5% as base diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.

Which are Apraclonidine Ophthalmic UNII Codes?

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

Which are Apraclonidine Ophthalmic 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 Apraclonidine Ophthalmic?

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: 308345 - apraclonidine HCl 0.5 % Ophthalmic Solution
  • RxCUI: 308345 - apraclonidine 5 MG/ML Ophthalmic Solution
  • RxCUI: 308345 - apraclonidine 0.5 % Ophthalmic Solution
  • RxCUI: 308345 - apraclonidine 5 MG/ML (apraclonidine hydrochloride 5.75 MG/ML) Ophthalmic Solution

* Please review the disclaimer below.

Patient Education

Apraclonidine Ophthalmic


Apraclonidine 0.5% eye drops are used for the short-term treatment of glaucoma (a condition that can cause damage to the optic nerve and vision loss, usually due to increased pressure in the eye) in people who are taking other medications for this condition and still have increased pressure in the eye. Apraclonidine 1% eye drops are used to prevent or reduce increased pressure in the eye during and after certain types of laser eye surgery. Apraclonidine is in a class of medications called alpha-2-adrenergic agonists. It lowers the pressure in the eye by decreasing the amount of fluid produced within the eye.
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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".