Apraclonidine Solution
NDC Package 61314-665-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Apraclonidine solution is apraclonidine Ophthalmic Solution, 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction. This formulation utilizes a solution delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-665 and is authorized under FDA application NDA020258.

Identification & Billing

NDC Package Code
61314-665-10
Package Description
10 mL in 1 BOTTLE
Product Code
61314-665
11-Digit Billing Format
61314066510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Apraclonidine
Non-Proprietary Name
Apraclonidine
Substance Name
Apraclonidine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
APRACLONIDINE HYDROCHLORIDE 5.75 mg/mL
Pharmacologic Class
Usage Information
Apraclonidine Ophthalmic Solution, 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 to delay surgery should have frequent followup examinations and treatment should be discontinued if the intraocular pressure rises significantly.The addition of Apraclonidine Ophthalmic Solution 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 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 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.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA020258
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-19-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61314-665). Click a package code to view its specific billing and regulatory data.

61314-665-05
5 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61314-665-10 identifies a specific commercial package of 10 ml in 1 bottle of Apraclonidine, a human prescription drug labeled by Sandoz Inc. This solution is formulated for ophthalmic use and contains apraclonidine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sandoz Inc on July 19, 2009. The current certification is valid through December 31, 2026.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314066510. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61314-665-10
11-Digit CMS (5-4-2)
61314-0665-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.