Fml (fluorometholone) NDC 11980-211

NDC codes

FDA NDC Directory

Product NDC (as listed)11980-211Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11980-0211Add 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
11980-211-05	11980021105	1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Feb 1, 1972
11980-211-10	11980021110	1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Feb 1, 1972

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): Fml
Generic name (nonproprietary): fluorometholone
Active ingredients: Fluorometholone — 1 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: Allergan, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016851
Marketing start: Feb 1, 1972
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 11980-211_000b0dad-a290-4a62-81ec-208e0a9c058bSPL ID 000b0dad-a290-4a62-81ec-208e0a9c058bSPL set ID c374d65a-35b5-4c9e-9069-5148875dc4dfRxCUI 310377, 545243UNII 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

N411980021105 followed by a unit qualifier and the quantity

Package 11980-0211-05. 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 FML ® suspension 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
Fluorometholone	Fluorometholone 1 mg/mL	Solution/ dropsOphthalmic	Pacific Pharma, Inc.	60758-880