ILEVRO
These highlights do not include all the information needed to use ILEVRO safely and effectively. See full prescribing information for ILEVRO. ILEVRO (nepafenac ophthalmic suspension), topical ophthalmicInitial U.S. Approval: 2005
Approved
Approval ID
f089b583-0310-4ca8-8d41-52b06b08d1ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nepafenac
PRODUCT DETAILS
NDC Product Code0078-0743
Application NumberNDA203491
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateMarch 17, 2020
Generic Namenepafenac
INGREDIENTS (12)
Boric AcidInactive
Code: R57ZHV85D4
Classification: IACT
NepafenacActive
Quantity: 3 mg in 1 mL
Code: 0J9L7J6V8C
Classification: ACTIB
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)Inactive
Code: HHT01ZNK31
Classification: IACT
Guar GumInactive
Code: E89I1637KE
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Carboxymethylcellulose SodiumInactive
Code: K679OBS311
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT