NDC Package 61314-656-10 Ciprofloxacin Hydrochloride

Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61314-656-10
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Ciprofloxacin Hydrochloride
Non-Proprietary Name:
Ciprofloxacin Hydrochloride
Substance Name:
Ciprofloxacin Hydrochloride
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.
11-Digit NDC Billing Format:
61314065610
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
  • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61314-656-051 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
    61314-656-251 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61314-656-10?

    The NDC Packaged Code 61314-656-10 is assigned to a package of 1 bottle, plastic in 1 carton / 10 ml in 1 bottle, plastic of Ciprofloxacin Hydrochloride, a human prescription drug labeled by Sandoz Inc. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 61314-656 included in the NDC Directory?

    Yes, Ciprofloxacin Hydrochloride with product code 61314-656 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on May 07, 2004 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61314-656-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 61314-656-10?

    The 11-digit format is 61314065610. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-261314-656-105-4-261314-0656-10