NDC 0065-9240

DUREZOL

Durezol

DUREZOL is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Difluprednate.

• Product ID: 0065-9240_4233aadc-4527-4431-94be-1b5604a9938e
• NDC: 0065-9240
• Product Type: Human Prescription Drug
• Proprietary Name: DUREZOL
• Generic Name: Durezol
• Dosage Form: Emulsion
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2011-01-25
• Marketing Category: NDA / NDA
• Application Number: NDA022212
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: DIFLUPREDNATE
• Active Ingredient Strength: 1 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0065-9240-07

1 BOTTLE in 1 CARTON (0065-9240-07) > 5 mL in 1 BOTTLE

• Marketing Start Date: 2013-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-9240-08 [00065924008]

DUREZOL EMULSION

• Marketing Category: NDA
• Application Number: NDA022212
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-15

NDC 0065-9240-07 [00065924007]

DUREZOL EMULSION

• Marketing Category: NDA
• Application Number: NDA022212
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-05-15

NDC 0065-9240-05 [00065924005]

DUREZOL EMULSION

• Marketing Category: NDA
• Application Number: NDA022212
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-01-25
• Marketing End Date: 2015-02-28

Drug Details

Active Ingredients

Ingredient	Strength
DIFLUPREDNATE	.5 mg/mL

OpenFDA Data

• SPL SET ID: d07b65d5-f8e3-4594-a7fb-108218746cec
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • S8A06QG2QE
• RxNorm Concept Unique ID - RxCUI:
  • 804544

NDC Crossover Matching brand name "DUREZOL" or generic name "Durezol"

NDC	Brand Name	Generic Name
0065-9240	DUREZOL	DUREZOL
0078-0862	DUREZOL	difluprednate
0781-6000	DUREZOL	Difluprednate Ophthalmic Emulsion