NDC 0023-0316

FML

Fluorometholone

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

• Product ID: 0023-0316_2926a3c5-53e3-4560-88d0-c26e61cb6be2
• NDC: 0023-0316
• Product Type: Human Prescription Drug
• Proprietary Name: FML
• Generic Name: Fluorometholone
• Dosage Form: Ointment
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1985-12-09
• Marketing Category: NDA / NDA
• Application Number: NDA017760
• Labeler Name: Allergan, Inc.
• Substance Name: FLUOROMETHOLONE
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0023-0316-04

1 TUBE in 1 CARTON (0023-0316-04) > 3.5 g in 1 TUBE

• Marketing Start Date: 1985-12-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-0316-04 [00023031604]

FML OINTMENT

• Marketing Category: NDA
• Application Number: NDA017760
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1985-12-09

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROMETHOLONE	1 mg/g

OpenFDA Data

• SPL SET ID: 3102d420-8842-4809-9aa1-7be91ac7d0ab
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • SV0CSG527L
• RxNorm Concept Unique ID - RxCUI:
  • 310374
  • 856935
• UPC Code:
  • 0300230316040

Pharmacological Class

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

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

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