Latanoprostene Bunod Ophthalmic Solution, 0.024%
These highlights do not include all the information needed to use LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION. LATANOPROSTENE BUNOD ophthalmic solution. Initial U.S. Approval: 2017
Approved
Approval ID
1beedfbd-5e2b-4ab1-ab8e-8320e69af1ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Latanoprostene Bunod Ophthalmic Solution, 0.024%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-564
Application NumberANDA217387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Latanoprostene Bunod Ophthalmic Solution, 0.024%
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (8)
LATANOPROSTENE BUNODActive
Quantity: 0.24 mg in 1 mL
Code: I6393O0922
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.2 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Latanoprostene Bunod Ophthalmic Solution, 0.024%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-563
Application NumberANDA217387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Latanoprostene Bunod Ophthalmic Solution, 0.024%
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (8)
LATANOPROSTENE BUNODActive
Quantity: 0.24 mg in 1 mL
Code: I6393O0922
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.2 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT