NDC 0065-1750

ILEVRO

Nepafenac

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

• Product ID: 0065-1750_36ff7e36-d529-4e61-ac2e-2e43d37629d8
• NDC: 0065-1750
• Product Type: Human Prescription Drug
• Proprietary Name: ILEVRO
• Generic Name: Nepafenac
• Dosage Form: Suspension
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2012-12-20
• Marketing End Date: 2021-11-30
• Marketing Category: NDA / NDA
• Application Number: NDA203491
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: NEPAFENAC
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0065-1750-14

1 BOTTLE, DROPPER in 1 CARTON (0065-1750-14) > 3 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2012-12-20
• Marketing End Date: 2021-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-1750-07 [00065175007]

ILEVRO SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203491
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-12-20

NDC 0065-1750-08 [00065175008]

ILEVRO SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203491
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-20

NDC 0065-1750-14 [00065175014]

ILEVRO SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203491
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-12-20

Drug Details

Active Ingredients

Ingredient	Strength
NEPAFENAC	3 mg/mL

OpenFDA Data

• SPL SET ID: 6c212466-ff8d-ecfc-ede2-ef8bdcaaf114
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • 0J9L7J6V8C
• RxNorm Concept Unique ID - RxCUI:
  • 1365866
  • 1362132
• 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 "ILEVRO" or generic name "Nepafenac"

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