Rocklatan
These highlights do not include all the information needed to use ROCKLATAN safely and effectively. See full prescribing information for ROCKLATAN. ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, for topical ophthalmic useInitial U.S. Approval: 2019
Approved
Approval ID
b1d71f41-be06-4a08-94d4-e352198f09c2
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 and latanoprost ophthalmic solution, 0.02%/0.005%
PRODUCT DETAILS
NDC Product Code70727-529
Application NumberNDA208259
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC, TOPICAL
Effective DateJune 2, 2020
Generic Namenetarsudil and latanoprost ophthalmic solution, 0.02%/0.005%
INGREDIENTS (7)
NETARSUDIL MESYLATEActive
Quantity: 0.20 mg in 1 mL
Code: VL756B1K0U
Classification: ACTIM
LATANOPROSTActive
Quantity: 0.05 mg in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT