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 ID0065-1750_36ff7e36-d529-4e61-ac2e-2e43d37629d8
NDC0065-1750
Product TypeHuman Prescription Drug
Proprietary NameILEVRO
Generic NameNepafenac
Dosage FormSuspension
Route of AdministrationOPHTHALMIC
Marketing Start Date2012-12-20
Marketing End Date2021-11-30
Marketing CategoryNDA / NDA
Application NumberNDA203491
Labeler NameAlcon Laboratories, Inc.
Substance NameNEPAFENAC
Active Ingredient Strength3 mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN

Packaging

NDC 0065-1750-14

1 BOTTLE, DROPPER in 1 CARTON (0065-1750-14) > 3 mL in 1 BOTTLE, DROPPER
Marketing Start Date2012-12-20
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-1750-07 [00065175007]

ILEVRO SUSPENSION
Marketing CategoryNDA
Application NumberNDA203491
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-12-20

NDC 0065-1750-08 [00065175008]

ILEVRO SUSPENSION
Marketing CategoryNDA
Application NumberNDA203491
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20

NDC 0065-1750-14 [00065175014]

ILEVRO SUSPENSION
Marketing CategoryNDA
Application NumberNDA203491
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-12-20

Drug Details

Active Ingredients

IngredientStrength
NEPAFENAC3 mg/mL

OpenFDA Data

SPL SET ID:6c212466-ff8d-ecfc-ede2-ef8bdcaaf114
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0065-1750ILEVROnepafenac
    0078-0743ILEVROnepafenac
    0065-0002NEVANACnepafenac
    0078-0778NEVANACnepafenac

    Trademark Results [ILEVRO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ILEVRO
    ILEVRO
    85716211 4397658 Live/Registered
    Novartis AG
    2012-08-29

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