Loteprednol Etabonate Suspension/ Drops
NDC Package 70244-034-03

11-digit billing NDC: 70244003403
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Loteprednol Etabonate suspension/ dropses is loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. This formulation utilizes a suspension/ drops delivery system. Marketed by Sentiss Pharmaceuticals Llc, this product is identified by NDC 70244-034 and is authorized under FDA application ANDA207609.

Identification & Billing

NDC Package Code
70244-034-03
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code
70244-034
11-Digit Billing Format
70244003403
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/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
LOTEPREDNOL ETABONATE 5 mg/mL
Pharmacologic Class
Usage Information
Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication.Loteprednol etabonate is also indicated for the treatment of post-operative inflammation following ocular surgery.

Regulatory & Marketing

Labeler Name
Sentiss Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207609
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-17-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70244-034). Click a package code to view its specific billing and regulatory data.

70244-034-01
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
70244-034-02
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

* 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 70244-034-03 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Loteprednol Etabonate, a human prescription drug labeled by Sentiss Pharmaceuticals Llc. This suspension/ drops 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 Sentiss Pharmaceuticals Llc on April 17, 2026. The current certification is valid through December 31, 2027.

How is this Sentiss Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70244003403. 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)
70244-034-03
11-Digit CMS (5-4-2)
70244-0034-03

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