NDC 11980-228

FML FORTE

Fluorometholone

FML FORTE is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Fluorometholone.

• Product ID: 11980-228_0222d745-11a7-4e8c-8edf-5ba4b36ffb06
• NDC: 11980-228
• Product Type: Human Prescription Drug
• Proprietary Name: FML FORTE
• Generic Name: Fluorometholone
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1986-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA019216
• Labeler Name: Allergan, Inc.
• Substance Name: FLUOROMETHOLONE
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 11980-228-05

1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 1986-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11980-228-15 [11980022815]

FML FORTE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019216
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-05-01
• Marketing End Date: 2010-10-31

NDC 11980-228-10 [11980022810]

FML FORTE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019216
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-05-01

NDC 11980-228-06 [11980022806]

FML FORTE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019216
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-10-31
• Marketing End Date: 2012-09-27

NDC 11980-228-05 [11980022805]

FML FORTE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019216
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-05-01

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROMETHOLONE	2.5 mg/mL

OpenFDA Data

• SPL SET ID: b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • SV0CSG527L
• RxNorm Concept Unique ID - RxCUI:
  • 208420
  • 310376
• UPC Code:
  • 0311980228057

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

11980022810 FML FORTE 0.25% EYE DROPS

Pricing Unit: ML | Drug Type:

11980022805 FML FORTE 0.25% EYE DROPS

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "FML FORTE" or generic name "Fluorometholone"

NDC	Brand Name	Generic Name
11980-228	FML FORTE	fluorometholone
60758-880	FLUOROMETHOLONE	fluorometholone
70518-1929	FLUOROMETHOLONE	fluorometholone
0023-0316	FML	fluorometholone
11980-211	FML	fluorometholone