Prescription drug · NDA
Fml Forte (Fluorometholone) NDC 11980-228
Fluorometholone 2.5 mg/mL · Suspension/ drops · Ophthalmic · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11980-228-05 | 1198002280511980022805 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 1, 1986 | |
| 11980-228-10 | 1198002281011980022810 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 1, 1986 |
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 Forte
- Generic name (nonproprietary)
- fluorometholone
- Active ingredients
- Fluorometholone — 2.5 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Allergan, Inc.NDC labeler code 11980
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019216
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9SPL ID 45789d76-a9c1-4ac5-84a1-fa2f9db729d9SPL set ID b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabfRxCUI 208420, 310376UNII SV0CSG527LUPC 0311980228057
- 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
N411980022805followed by a unit qualifier and the quantityPackage 11980-0228-05. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE FML FORTE ® 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.
About NDC 11980-228
- What is NDC 11980-228?
- 11980-228 is the product NDC for Fml Forte (fluorometholone), Fluorometholone 2.5 mg/mL suspension/ drops, listed with the FDA by Allergan, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fml Forte (Fluorometholone).
- What is the active ingredient?
- Fluorometholone.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 11980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fml Forte?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.