Loteprednol Etabonate NDC 70244-035

NDC codes

FDA NDC Directory

Product NDC (as listed)70244-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70244-0035Add 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
70244-035-01	70244003501	1 BOTTLE, DROPPER in 1 CARTON (70244-035-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 17, 2026
70244-035-02	70244003502	1 BOTTLE, DROPPER in 1 CARTON (70244-035-02) / 10 mL in 1 BOTTLE, DROPPERMarketed from Apr 17, 2026

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: Sentiss Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215933
Marketing start: Apr 17, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 70244-035_4fab1f66-7939-f43d-e063-6294a90a29acSPL ID 4fab1f66-7939-f43d-e063-6294a90a29acSPL set ID f210d817-409f-4e69-b8d0-58883c0b43d3RxCUI 311381UNII 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

N470244003501 followed by a unit qualifier and the quantity

Package 70244-0035-01. 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 17, 2026.

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	ARMAS PHARMACEUTICALS INC.	72485-653