Rhopressa
These highlights do not include all the information needed to use RHOPRESSA safely and effectively. See full prescribing information for RHOPRESSA. RHOPRESSA (netarsudil ophthalmic solution) 0.02%, for topical ophthalmic use Initial U.S. Approval: 2017
Approved
Approval ID
7d4f0e3a-5b86-4c43-982a-813b22ae7e22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2023
Manufacturers
FDA
Alcon Laboratories, Inc.
DUNS: 008018525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
netarsudil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70727-497
Application NumberNDA208254
Product Classification
M
Marketing Category
C73594
G
Generic Name
netarsudil
Product Specifications
Route of AdministrationOPHTHALMIC, TOPICAL
Effective DateMarch 25, 2019
FDA Product Classification
INGREDIENTS (6)
NETARSUDIL MESYLATEActive
Quantity: 0.200 mg in 1 mL
Code: VL756B1K0U
Classification: ACTIM
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT