Loteprednol Etabonate NDC 0574-4135

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-4135Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-4135Add 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
0574-4135-05	00574413505	1 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jan 12, 2026
0574-4135-10	00574413510	1 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jan 12, 2026
0574-4135-15	00574413515	1 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jan 12, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Padagis US LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215204
Marketing start: Jan 12, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82aSPL ID 1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82aSPL set ID 55ec893d-4955-4d2c-8b5b-84f462d23e02RxCUI 311382UNII YEH1EZ96K6
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

N400574413505 followed by a unit qualifier and the quantity

Package 00574-4135-05. 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 Apr 1, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loteprednol etabonate ophthalmic suspension 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 ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with lotepred…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)