Ciprofloxacin Hydrochloride
NDC Package 45865-877-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ciprofloxacin Hydrochloride is ophthalmic Solution 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 influenzaeStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae*Efficacy for this organism was studied in fewer than 10 infections. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-877 and is authorized under FDA application NDA019992.

Identification & Billing

NDC Package Code
45865-877-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC
Product Code
45865-877
11-Digit Billing Format
45865087701
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 Hydrochloride
Dosage Form
-
Usage Information
Ciprofloxacin Hydrochloride Ophthalmic Solution 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 influenzaeStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae*Efficacy for this organism was studied in fewer than 10 infections.

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
NDA019992
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
05-07-2004
Listing Expiration
12-31-2024
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45865-877-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic of Ciprofloxacin Hydrochloride, labeled by Medsource Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medsource Pharmaceuticals on May 07, 2004. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865087701. 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)
45865-877-01
11-Digit CMS (5-4-2)
45865-0877-01

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