Loteprednol Etabonate NDC 72485-653

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-653Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0653Add 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
72485-653-05	72485065305	1 BOTTLE, DROPPER in 1 CARTON (72485-653-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 24, 2023
72485-653-10	72485065310	1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 24, 2023

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
Generic name (nonproprietary): loteprednol etabonate
Active ingredients: Loteprednol etabonate — 2 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: ARMAS PHARMACEUTICALS INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215933
Marketing start: Oct 24, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 72485-653_1a784c5a-bdb4-c5b8-e063-6394a90a8f9cSPL ID 1a784c5a-bdb4-c5b8-e063-6394a90a8f9cSPL set ID 36c05fa4-6562-4af8-86ac-e79003ee65ddRxCUI 311381UNII YEH1EZ96K6UPC 0372485653058, 0372485653102
Pharmacologic class: 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

N472485065305 followed by a unit qualifier and the quantity

Package 72485-0653-05. 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 May 31, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215933

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

FDA NDC Directory listings under ANDA 215933
Product	Strength	Form · route	Labeler	Product NDC
Loteprednol Etabonate	Loteprednol etabonate 2 mg/mL	Suspension/ dropsOphthalmic	Sportpharm LLC	85766-193
Loteprednol Etabonate	Loteprednol etabonate 2 mg/mL	Suspension/ dropsOphthalmic	Sentiss Pharmaceuticals LLC	70244-035