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) |
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 NDC: | 31357-040-25 |
Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (31357-040-25) > 2.5 mL in 1 BOTTLE, DROPPER |
NDC Code | 31357-040-25 |
Proprietary Name | AzaSite |
Package Description | 1 BOTTLE, DROPPER in 1 CARTON (31357-040-25) > 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] |