Loteprednol Etabonate Suspension
NDC Package 70748-300-01

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

Loteprednol Etabonate suspension is a medication used to treat certain eye conditions due to inflammation or injury. This formulation utilizes a suspension delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 70748-300 and is authorized under FDA application ANDA215719.

Identification & Billing

NDC Package Code
70748-300-01
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
70748-300
11-Digit Billing Format
70748030001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 311382 - loteprednol etabonate 0.5 % Ophthalmic Suspension
  • RxCUI: 311382 - loteprednol etabonate 5 MG/ML Ophthalmic Suspension

Clinical Specifications

Proprietary Name
Loteprednol Etabonate
Non-Proprietary Name
Loteprednol Etabonate
Substance Name
Loteprednol Etabonate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
LOTEPREDNOL ETABONATE 5 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat certain eye conditions due to inflammation or injury. It is also used 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
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215719
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70748-300). Click a package code to view its specific billing and regulatory data.

70748-300-02
1 BOTTLE in 1 CARTON / 10 mL 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 70748-300-01 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Loteprednol Etabonate, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This suspension 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 Lupin Pharmaceuticals, Inc. on July 15, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain eye conditions due to inflammation or injury. It is also used 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 Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70748030001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
70748-300-01
11-Digit CMS (5-4-2)
70748-0300-01

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