Nevanac
These highlights do not include all the information needed to use nevanac safely and effectively. See full prescribing information for nevanac. nevanac (nepafenac) suspension for ophthalmic use Initial U.S. Approval: 2005
Approved
Approval ID
52fe0332-388a-451c-b759-97e760883837
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nepafenac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6302
Application NumberNDA021862
Product Classification
M
Marketing Category
C73594
G
Generic Name
nepafenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 31, 2011
FDA Product Classification
INGREDIENTS (10)
NEPAFENACActive
Quantity: 1 mg in 1 mL
Code: 0J9L7J6V8C
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: K61870Z308
Classification: IACT