LATANOPROST
These highlights do not include all the information needed to use Latanoprost Ophthalmic Solution safely and effectively. See full prescribing information for Latanoprost Ophthalmic Solution. Latanoprost Ophthalmic Solution 0.005% Initial U.S. Approval:1996
Approved
Approval ID
891a5db6-ca9b-48f0-b3c6-7cd56e310c5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2019
Manufacturers
FDA
FDC Limited
DUNS: 650441301
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
latanoprost
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55545-1010
Application NumberANDA202442
Product Classification
M
Marketing Category
C73584
G
Generic Name
latanoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 29, 2019
FDA Product Classification
INGREDIENTS (5)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB