Loteprednol Etabonate And Tobramycin Suspension/ Drops
NDC Package 46708-801-05

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 And Tobramycin suspension/ dropses is loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% is a topical anti- infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in 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, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. This formulation utilizes a suspension/ drops delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-801 and is authorized under FDA application ANDA217597.

Identification & Billing

NDC Package Code
46708-801-05
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
46708-801
11-Digit Billing Format
46708080105
RxNorm Crosswalk
  • RxCUI: 545255 - loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension
  • RxCUI: 545255 - loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension

Clinical Specifications

Proprietary Name
Loteprednol Etabonate And Tobramycin
Non-Proprietary Name
Loteprednol Etabonate And Tobramycin
Substance Name
Loteprednol Etabonate; Tobramycin
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)
Pharmacologic Class
Usage Information
Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% is a topical anti- infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in 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, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens:  Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217597
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2025
Listing Expiration
12-31-2026
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 (46708-801). Click a package code to view its specific billing and regulatory data.

46708-801-10
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 46708-801-05 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Loteprednol Etabonate And Tobramycin, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This suspension/ drops is formulated for ophthalmic use and contains loteprednol etabonate; tobramycin 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 Alembic Pharmaceuticals Limited on December 10, 2025. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708080105. 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)
46708-801-05
11-Digit CMS (5-4-2)
46708-0801-05

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