AZASITE
These highlights do not include all the information needed to use AzaSite safely and effectively. See full prescribing information for AzaSite. AzaSite (azithromycin ophthalmic solution) 1% Sterile topical ophthalmic drops Initial U.S. Approval: 2007
Approved
Approval ID
0c5d6f5e-18ea-436f-8c62-bbaf66effe3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2023
Manufacturers
FDA
Thea Pharma Inc.
DUNS: 117787029
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82584-307
Application NumberNDA050810
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin monohydrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.03 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
AZITHROMYCIN MONOHYDRATEActive
Quantity: 10 mg in 1 mL
Code: JTE4MNN1MD
Classification: ACTIM
POLYCARBOPHILInactive
Code: W25LM17A4W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT