Ofloxacin Solution
NDC Package 68071-5337-1

11-digit billing NDC: 68071533701
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ofloxacin solution is ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:CONJUNCTIVITIS:            Gram-positive bacteria:            Staphylococcus aureus            Staphylococcus epidermidis            Streptococcus pneumoniaeGram-negative bacteria:Enterobacter cloacaeHaemophilus influenzaeProteus mirabilisPseudomonas aeruginosaCORNEAL ULCERS:           Gram-positive bacteria:           Staphylococcus aureus           Staphylococcus epidermidis           Streptococcus pneumoniaeGram-negative bacteria:Pseudomonas aeruginosaSerratia marcescens Efficacy for this organism was studied in fewer than 10 infectionsAnaerobic species:Propionibacterium acnes. This formulation utilizes a solution delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-5337 and is authorized under FDA application ANDA217904.

Identification & Billing

NDC Package Code
68071-5337-1
Package Description
10 mL in 1 BOTTLE, DROPPER
Product Code
68071-5337
11-Digit Billing Format
68071533701

Clinical Specifications

Proprietary Name
Ofloxacin
Non-Proprietary Name
Ofloxacin
Substance Name
Ofloxacin
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)
OFLOXACIN 3 mg/mL
Pharmacologic Class
Usage Information
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:CONJUNCTIVITIS:            Gram-positive bacteria:            Staphylococcus aureus            Staphylococcus epidermidis            Streptococcus pneumoniaeGram-negative bacteria:Enterobacter cloacaeHaemophilus influenzaeProteus mirabilisPseudomonas aeruginosaCORNEAL ULCERS:           Gram-positive bacteria:           Staphylococcus aureus           Staphylococcus epidermidis           Streptococcus pneumoniaeGram-negative bacteria:Pseudomonas aeruginosaSerratia marcescens Efficacy for this organism was studied in fewer than 10 infectionsAnaerobic species:Propionibacterium acnes

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217904
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2024
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-5337-1 identifies a specific commercial package of 10 ml in 1 bottle, dropper of Ofloxacin, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This solution is formulated for ophthalmic use and contains ofloxacin 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 Nucare Pharmaceuticals, Inc. on July 15, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071533701. 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 (5-4-1)
68071-5337-1
11-Digit CMS (5-4-2)
68071-5337-01

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