Lotemax Sm Gel
NDC Package 24208-507-01

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

Lotemax Sm (loteprednol etabonate) gel is a medication used to treat eye inflammation and pain after eye surgery. This formulation utilizes a gel delivery system. Marketed by Bausch & Lomb Incorporated, this product is identified by NDC 24208-507 and is authorized under FDA application NDA208219.

Identification & Billing

NDC Package Code
24208-507-01
Package Description
1 BOTTLE in 1 CARTON / .5 g in 1 BOTTLE
Product Code
24208-507
11-Digit Billing Format
24208050701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lotemax Sm
Non-Proprietary Name
Loteprednol Etabonate
Substance Name
Loteprednol Etabonate
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
LOTEPREDNOL ETABONATE 3.8 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat eye inflammation and pain after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Bausch & Lomb Incorporated
Product Type
Human Prescription Drug
FDA Application #
NDA208219
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-25-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (24208-507). Click a package code to view its specific billing and regulatory data.

24208-507-02
1 BOTTLE in 1 CARTON / 5 g in 1 BOTTLE
24208-507-07
1 BOTTLE in 1 CARTON / 5 g in 1 BOTTLE

* 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 24208-507-01 identifies a specific commercial package of 1 bottle in 1 carton / .5 g in 1 bottle of Lotemax Sm, a human prescription drug labeled by Bausch & Lomb Incorporated. This gel is formulated for ophthalmic use and contains loteprednol etabonate 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 Bausch & Lomb Incorporated on February 25, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat eye inflammation and pain after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

How is this Bausch & Lomb Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24208050701. 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)
24208-507-01
11-Digit CMS (5-4-2)
24208-0507-01

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