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  5. NDC Package Code: 70748-300-01 Loteprednol Etabonate

NDC Package 70748-300-01 Loteprednol Etabonate

Suspension Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
70748-300-01
Package Description:
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code:
70748-300
Proprietary Name:
Loteprednol Etabonate
Non-Proprietary Name:
Loteprednol Etabonate
Substance Name:
Loteprednol Etabonate
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.
11-Digit NDC Billing Format:
70748030001
NDC to RxNorm Crosswalk:
  • RxCUI: 311382 - loteprednol etabonate 0.5 % Ophthalmic Suspension
  • RxCUI: 311382 - loteprednol etabonate 5 MG/ML Ophthalmic Suspension
Product Type:
Human Prescription Drug
Labeler Name:
Lupin Pharmaceuticals, Inc.
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s):
Ophthalmic - Administration to the external eye.
Active Ingredient(s):
LOTEPREDNOL ETABONATE 5 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA215719
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-01-2025
Listing Expiration Date:
12-31-2026
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
70748-300-021 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
70748-300-031 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70748-300-01?

The NDC Packaged Code 70748-300-01 is assigned to a package of 1 bottle in 1 carton / 5 ml in 1 bottle of Loteprednol Etabonate, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is suspension and is administered via ophthalmic form.

Is NDC 70748-300 included in the NDC Directory?

Yes, Loteprednol Etabonate with product code 70748-300 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals, Inc. on July 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 70748-300-01?

The 11-digit format is 70748030001. 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
5-3-270748-300-015-4-270748-0300-01