Ciprofloxacin Hcl Ophthalmic Solution
NDC Package 59390-217-05

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

Ciprofloxacin Hcl Ophthalmic (ciprofloxacin hydrochloride) solution is ciprofloxacin Ophthalmic Solution, USP 0.3% is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:Corneal Ulcers:       Pseudomonas aeruginosaSerratia marcescens *Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Viridans Group)*Conjunctivitis:       Haemophilus influenzaStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae*Efficacy for this organism was studied in fewer than 10 infections. This formulation utilizes a solution delivery system. Marketed by Altaire Pharmaceuticals Inc., this product is identified by NDC 59390-217 and is authorized under FDA application ANDA204613.

Identification & Billing

NDC Package Code
59390-217-05
Package Description
5 mL in 1 BOTTLE, PLASTIC
Product Code
59390-217
11-Digit Billing Format
59390021705
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk
  • RxCUI: 309307 - ciprofloxacin HCl 0.3 % Ophthalmic Solution
  • RxCUI: 309307 - ciprofloxacin 3 MG/ML Ophthalmic Solution
  • RxCUI: 309307 - ciprofloxacin 0.3 % Ophthalmic Solution
  • RxCUI: 309307 - ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution

Clinical Specifications

Proprietary Name
Ciprofloxacin Hcl Ophthalmic
Non-Proprietary Name
Ciprofloxacin Hydrochloride
Substance Name
Ciprofloxacin 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)
CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL
Pharmacologic Class
Usage Information
Ciprofloxacin Ophthalmic Solution, USP 0.3% is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:Corneal Ulcers:       Pseudomonas aeruginosaSerratia marcescens *Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Viridans Group)*Conjunctivitis:       Haemophilus influenzaStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae*Efficacy for this organism was studied in fewer than 10 infections.

Regulatory & Marketing

Labeler Name
Altaire Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204613
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-04-2018
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 (59390-217). Click a package code to view its specific billing and regulatory data.

59390-217-02
2.5 mL in 1 BOTTLE, PLASTIC
59390-217-10
10 mL in 1 BOTTLE, PLASTIC

* 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 59390-217-05 identifies a specific commercial package of 5 ml in 1 bottle, plastic of Ciprofloxacin Hcl Ophthalmic, a human prescription drug labeled by Altaire Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This solution is formulated for ophthalmic use and contains ciprofloxacin 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 Altaire Pharmaceuticals Inc. on May 04, 2018. The current certification is valid through December 31, 2026.

How is this Altaire Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59390021705. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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)
59390-217-05
11-Digit CMS (5-4-2)
59390-0217-05

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