Loteprednol Etabonate NDC 72485-665

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-665Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0665Add 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
72485-665-05	72485066505	1 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 26, 2023
72485-665-10	72485066510	1 BOTTLE, DROPPER in 1 CARTON (72485-665-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 26, 2023
72485-665-15	72485066515	1 BOTTLE, DROPPER in 1 CARTON (72485-665-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Oct 26, 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 — 5 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 207609
Marketing start: Oct 26, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 72485-665_08a09440-b505-b2c9-e063-6394a90a0d76SPL ID 08a09440-b505-b2c9-e063-6394a90a0d76SPL set ID 08a091a8-748f-acc4-e063-6394a90af4bcRxCUI 311382UNII YEH1EZ96K6UPC 0372485665105, 0372485665150, 0372485665051
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

N472485066505 followed by a unit qualifier and the quantity

Package 72485-0665-05. 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 Oct 26, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 ante…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207609

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

FDA NDC Directory listings under ANDA 207609
Product	Strength	Form · route	Labeler	Product NDC
Loteprednol Etabonate	Loteprednol etabonate 5 mg/mL	Suspension/ dropsOphthalmic	Sentiss Pharmaceuticals LLC	70244-034