Fluorometholone NDC 60758-880

NDC codes

FDA NDC Directory

Product NDC (as listed)60758-880Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60758-0880Add 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
60758-880-05	60758088005	1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 31, 1997
60758-880-10	60758088010	1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 31, 1997

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): Fluorometholone
Generic name (nonproprietary): fluorometholone
Active ingredients: Fluorometholone — 1 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Pacific Pharma, Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 016851
Marketing start: Oct 31, 1997
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 60758-880_03ccffb8-f63a-4c2e-9c19-7cb85f24e554SPL ID 03ccffb8-f63a-4c2e-9c19-7cb85f24e554SPL set ID af59c420-789d-4c05-b3fc-c3f855bcac24RxCUI 310377UNII SV0CSG527L
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

N460758088005 followed by a unit qualifier and the quantity

Package 60758-0880-05. 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 Dec 1, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 016851

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

FDA NDC Directory listings under NDA 016851
Product	Strength	Form · route	Labeler	Product NDC
Fmlfluorometholone	Fluorometholone 1 mg/mL	Suspension/ dropsOphthalmic	Allergan, Inc.	11980-211