Loteprednol etabonate and Tobramycin NDC 62332-801

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0801Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
62332-801-05	62332080105	1 BOTTLE in 1 CARTON (62332-801-05) / 5 mL in 1 BOTTLEMarketed from Dec 10, 2025
62332-801-10	62332080110	1 BOTTLE in 1 CARTON (62332-801-10) / 10 mL in 1 BOTTLEMarketed from Dec 10, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Loteprednol etabonate and Tobramycin
Generic name (nonproprietary): loteprednol etabonate and tobramycin
Active ingredients: Loteprednol etabonate — 5 mg/mLTobramycin — 3 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217597
Marketing start: Dec 10, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 62332-801_d34d6f39-c5c7-40ea-89da-977c6e1eaa05SPL ID d34d6f39-c5c7-40ea-89da-977c6e1eaa05SPL set ID 7c752fac-8ec8-49ab-8570-09d2aabbeef0RxCUI 545255UNII YEH1EZ96K6, VZ8RRZ51VK
Pharmacologic class: Aminoglycoside Antibacterial; Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462332080105 followed by a unit qualifier and the quantity

Package 62332-0801-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 11, 2025.

Indications (excerpt from the label)

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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217597

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217597
Product	Strength	Form · route	Labeler	Product NDC
Loteprednol etabonate and Tobramycin	Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL	Suspension/ dropsOphthalmic	Alembic Pharmaceuticals Limited	46708-801