NEVANAC
These highlights do not include all the information needed to use NEVANAC safely and effectively. See full prescribing information for NEVANAC. NEVANAC (nepafenac ophthalmic suspension) 0.1%, for topical ophthalmic use Initial U.S. Approval: 2005
Approved
Approval ID
a2909252-c5f1-421f-9073-b7be90b45b51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 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 Code0078-0778
Application NumberNDA021862
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateSeptember 6, 2021
Generic Namenepafenac
INGREDIENTS (10)
NEPAFENACActive
Quantity: 1 mg in 1 mL
Code: 0J9L7J6V8C
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT