| 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] |