What is NDC 0574-4080?

0574-4080 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 2 mg/mL suspension/ drops, listed with the FDA by Padagis US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Loteprednol Etabonate?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loteprednol Etabonate NDC 0574-4080 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-4080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-4080Add 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
0574-4080-05	00574408005	1 BOTTLE, DROPPER in 1 CARTON (0574-4080-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 2026
0574-4080-10	00574408010	1 BOTTLE, DROPPER in 1 CARTON (0574-4080-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 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 — 2 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215203
Marketing start: Mar 31, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0574-4080_d37c000f-f673-4dce-be90-8b6f47777b7bSPL ID d37c000f-f673-4dce-be90-8b6f47777b7bSPL set ID 63372922-4d41-4d81-8d9b-eebaf44acabfRxCUI 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

N400574408005 followed by a unit qualifier and the quantity

Package 00574-4080-05. 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, 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)

About NDC 0574-4080

What is NDC 0574-4080?: 0574-4080 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 2 mg/mL suspension/ drops, listed with the FDA by Padagis US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loteprednol Etabonate.
What is the active ingredient?: Loteprednol etabonate.
Who is the labeler?: Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Loteprednol Etabonate?: 18 other product NDCs are listed under this name. See all Loteprednol Etabonate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Loteprednol Etabonate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loteprednol Etabonate	Loteprednol etabonate 5 mg/mL	Suspension/ dropsOphthalmic	Sentiss Pharmaceuticals LLC	70244-034	70244-0034-0170244-0034-0270244-0034-03
Loteprednol Etabonate	Loteprednol etabonate 2 mg/mL	Suspension/ dropsOphthalmic	Sentiss Pharmaceuticals LLC	70244-035	70244-0035-0170244-0035-02
Loteprednol Etabonate	Loteprednol etabonate 5 mg/g	GelOphthalmic	Sentiss Pharmaceuticals LLC	70244-036	70244-0036-01
Loteprednol Etabonate	Loteprednol etabonate 5 mg/mL	Suspension/ dropsOphthalmic	Padagis US LLC	0574-4135	00574-4135-0500574-4135-1000574-4135-15
loteprednol etabonate	Loteprednol etabonate 5 mg/mL	SuspensionOphthalmic	Lupin Pharmaceuticals, Inc.	70748-300	70748-0300-0170748-0300-02
Loteprednol Etabonate	Loteprednol etabonate 5 mg/mL	Suspension/ dropsOphthalmic	Amneal Pharmaceuticals NY LLC	60219-1362	60219-1362-0160219-1362-0260219-1362-03
loteprednol etabonate	Loteprednol etabonate 2 mg/mL	Suspension/ dropsOphthalmic	Amneal Pharmaceuticals NY LLC	60219-1366	60219-1366-03
loteprednol etabonate	Loteprednol etabonate 2 mg/mL	Suspension/ dropsOphthalmic	Amneal Pharmaceuticals NY LLC	60219-1367	60219-1367-06
Loteprednol Etabonate	Loteprednol etabonate 5 mg/mL	Suspension/ dropsOphthalmic	NorthStar RxLLC	72603-324	72603-0324-0172603-0324-0272603-0324-03
loteprednol etabonate	Loteprednol etabonate 2 mg/mL	Suspension/ dropsOphthalmic	Bausch & Lomb Americas Inc.	82260-361	82260-0361-05

All 19 Loteprednol Etabonate NDCs