NDC 70518-1929

FLUOROMETHOLONE

Fluorometholone

FLUOROMETHOLONE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Fluorometholone.

• Product ID: 70518-1929_8312d106-8da0-d782-e053-2a91aa0a47d6
• NDC: 70518-1929
• Product Type: Human Prescription Drug
• Proprietary Name: FLUOROMETHOLONE
• Generic Name: Fluorometholone
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-03-01
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA016851
• Labeler Name: REMEDYREPACK INC.
• Substance Name: FLUOROMETHOLONE
• 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 70518-1929-0

1 BOTTLE, DROPPER in 1 CARTON (70518-1929-0) > 10 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1929-0 [70518192900]

FLUOROMETHOLONE SOLUTION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA016851
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROMETHOLONE	1 mg/mL

OpenFDA Data

• SPL SET ID: 0c92b04d-deec-4f53-a65b-7f9414b3aa3f
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • SV0CSG527L
• RxNorm Concept Unique ID - RxCUI:
  • 310377

Pharmacological Class

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

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

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