What is NDC 72485-630?

72485-630 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 5 mg/g gel, listed with the FDA by ARMAS PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

ARMAS PHARMACEUTICALS INC., NDC labeler code 72485. 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 72485-630

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0630Add 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
72485-630-05	7248506300572485063005	1 BOTTLE, DROPPER in 1 CARTON (72485-630-05) / 5 g in 1 BOTTLE, DROPPERMarketed from Oct 25, 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/g
Dosage form: Gel
Route: Ophthalmic
Labeler: ARMAS PHARMACEUTICALS INC.NDC labeler code 72485
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212080
Marketing start: Oct 25, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 72485-630_0919fa30-ff66-f021-e063-6394a90ae4bbSPL ID 0919fa30-ff66-f021-e063-6394a90ae4bbSPL set ID 091a068f-f9b0-b02b-e063-6294a90a95e6RxCUI 1312625UNII 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

N472485063005 followed by a unit qualifier and the quantity

Package 72485-0630-05. 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 25, 2023.

Indications (excerpt from the label)

Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72485-630

What is NDC 72485-630?: 72485-630 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 5 mg/g gel, listed with the FDA by ARMAS PHARMACEUTICALS INC.. It has 1 package NDC, 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?: ARMAS PHARMACEUTICALS INC., NDC labeler code 72485. 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 2 mg/mL	Suspension/ dropsOphthalmic	Padagis US LLC	0574-4080	00574-4080-0500574-4080-10
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	72603-0324-01

All 19 Loteprednol Etabonate NDCs

Other NDCs under ANDA 212080

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

FDA NDC Directory listings under ANDA 212080
Product	Strength	Form · route	Labeler	Product NDC
Loteprednol Etabonate	Loteprednol etabonate 5 mg/g	GelOphthalmic	Sentiss Pharmaceuticals LLC	70244-036