NDC 71776-100

Flarex

Fluorometholone Acetate

Flarex is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Eyevance Pharmaceuticals. The primary component is Fluorometholone Acetate.

• Product ID: 71776-100_83d82d00-bc7d-db0b-e053-2991aa0a330f
• NDC: 71776-100
• Product Type: Human Prescription Drug
• Proprietary Name: Flarex
• Generic Name: Fluorometholone Acetate
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-03-05
• Marketing Category: NDA / NDA
• Application Number: NDA019079
• Labeler Name: Eyevance Pharmaceuticals
• Substance Name: FLUOROMETHOLONE ACETATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71776-100-05

1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) > 5 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2019-03-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71776-100-05 [71776010005]

Flarex SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019079
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-05

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROMETHOLONE ACETATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 19918ea5-8568-44d6-b8ee-7b2197cee85c
• Manufacturer:
  • Eyevance Pharmaceuticals
• UNII:
  • 9I50C3I3OK
• RxNorm Concept Unique ID - RxCUI:
  • 1249631
  • 1249629
• UPC Code:
  • 0371776100059

Pharmacological Class

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

NDC Crossover Matching brand name "Flarex" or generic name "Fluorometholone Acetate"

NDC	Brand Name	Generic Name
0065-0096	Flarex	fluorometholone acetate
71776-100	Flarex	fluorometholone acetate