AzaSite - 31357-040-03 - (azithromycin)

Alphabetical Index


Drug Information of AzaSite

Product NDC: 31357-040
Proprietary Name: AzaSite
Non Proprietary Name: azithromycin
Active Ingredient(s): 10    mg/mL & nbsp;   azithromycin
Administration Route(s): OPHTHALMIC
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of AzaSite

Product NDC: 31357-040
Labeler Name: Inspire Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA050810
Marketing Category: NDA
Start Marketing Date: 20070716

Package Information of AzaSite

Package NDC: 31357-040-03
Package Description: 1 BOTTLE, DROPPER in 1 CARTON (31357-040-03) > 2.5 mL in 1 BOTTLE, DROPPER

NDC Information of AzaSite

NDC Code 31357-040-03
Proprietary Name AzaSite
Package Description 1 BOTTLE, DROPPER in 1 CARTON (31357-040-03) > 2.5 mL in 1 BOTTLE, DROPPER
Product NDC 31357-040
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name azithromycin
Dosage Form Name SOLUTION
Route Name OPHTHALMIC
Start Marketing Date 20070716
Marketing Category Name NDA
Labeler Name Inspire Pharmaceuticals, Inc.
Substance Name AZITHROMYCIN MONOHYDRATE
Strength Number 10
Strength Unit mg/mL
Pharmaceutical Classes Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]

Complete Information of AzaSite


General Information