Latanoprost
Latanoprost Ophthalmic Solution 0.005% (50 ug/mL)
Approved
Approval ID
213a0003-da2b-4b91-9281-c05a73f94e46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-986
Application NumberANDA201006
Product Classification
M
Marketing Category
C73584
G
Generic Name
Latanoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 10, 2010
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT