NDC 0065-0002

NEVANAC

Nepafenac

NEVANAC is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Nepafenac.

• Product ID: 0065-0002_01a34750-69f1-4871-b8cf-1f5bc1badfdf
• NDC: 0065-0002
• Product Type: Human Prescription Drug
• Proprietary Name: NEVANAC
• Generic Name: Nepafenac
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2005-09-06
• Marketing Category: NDA / NDA
• Application Number: NDA021862
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: NEPAFENAC
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0065-0002-03

3 mL in 1 BOTTLE, PLASTIC (0065-0002-03)

• Marketing Start Date: 2005-09-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0002-01 [00065000201]

NEVANAC SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021862
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-09-06
• Marketing End Date: 2018-02-09

NDC 0065-0002-03 [00065000203]

NEVANAC SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021862
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-09-06

Drug Details

Active Ingredients

Ingredient	Strength
NEPAFENAC	1 mg/mL

OpenFDA Data

• SPL SET ID: 3ad48650-75e3-4c74-9302-01b0088f164e
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • 0J9L7J6V8C
• RxNorm Concept Unique ID - RxCUI:
  • 603978
  • 578044
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "NEVANAC" or generic name "Nepafenac"

NDC	Brand Name	Generic Name
0065-0002	NEVANAC	nepafenac
0078-0778	NEVANAC	nepafenac
0065-1750	ILEVRO	nepafenac
0078-0743	ILEVRO	nepafenac