Ofloxacin Solution
NDC Package 42571-461-92

11-digit billing NDC: 42571046192
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ofloxacin (ofloxacin ophthalmic) 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 aureusStaphylococcus epidermidisStreptococcus pneumoniaeGram-negative bacteria:Enterobacter cloacaeHaemophilus influenzaeProteus mirabilisPseudomonas aeruginosaCORNEAL ULCERS:Gram-positive bacteria:Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae   Gram-negative bacteria:Pseudomonas aeruginosaSerratia marcescens*Anaerobic species:Propionibacterium acnes*Efficacy for this organism was studied in fewer than 10 infections. This formulation utilizes a solution delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-461 and is authorized under FDA application ANDA218557.

Identification & Billing

NDC Package Code
42571-461-92
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
42571-461
11-Digit Billing Format
42571046192

Clinical Specifications

Proprietary Name
Ofloxacin
Non-Proprietary Name
Ofloxacin Ophthalmic
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 aureusStaphylococcus epidermidisStreptococcus pneumoniaeGram-negative bacteria:Enterobacter cloacaeHaemophilus influenzaeProteus mirabilisPseudomonas aeruginosaCORNEAL ULCERS:Gram-positive bacteria:Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae   Gram-negative bacteria:Pseudomonas aeruginosaSerratia marcescens*Anaerobic species:Propionibacterium acnes*Efficacy for this organism was studied in fewer than 10 infections

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218557
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-15-2026
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 42571-461-92 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Ofloxacin, a human prescription drug labeled by Micro Labs Limited. 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 Micro Labs Limited on October 15, 2026. The current certification is valid through December 31, 2027.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571046192. 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)
42571-461-92
11-Digit CMS (5-4-2)
42571-0461-92

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