Product NDC: | 63323-398 |
Proprietary Name: | Azithromycin |
Non Proprietary Name: | AZITHROMYCIN MONOHYDRATE |
Active Ingredient(s): | 500 mg/5mL & nbsp; AZITHROMYCIN MONOHYDRATE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-398 |
Labeler Name: | Fresenius Kabi USA, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA065179 |
Marketing Category: | ANDA |
Start Marketing Date: | 20060320 |
Package NDC: | 63323-398-10 |
Package Description: | 10 VIAL in 1 TRAY (63323-398-10) > 5 mL in 1 VIAL |
NDC Code | 63323-398-10 |
Proprietary Name | Azithromycin |
Package Description | 10 VIAL in 1 TRAY (63323-398-10) > 5 mL in 1 VIAL |
Product NDC | 63323-398 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | AZITHROMYCIN MONOHYDRATE |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20060320 |
Marketing Category Name | ANDA |
Labeler Name | Fresenius Kabi USA, LLC |
Substance Name | AZITHROMYCIN MONOHYDRATE |
Strength Number | 500 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] |