Azithromycin monohydrate is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Azithromycin Monohydrate.
| Product ID | 68083-199_2427342f-14b2-4e21-a07e-58edde96e7a8 |
| NDC | 68083-199 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Azithromycin monohydrate |
| Generic Name | Azithromycin Monohydrate |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2009-11-09 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA065501 |
| Labeler Name | Gland Pharma Limited |
| Substance Name | AZITHROMYCIN MONOHYDRATE |
| Active Ingredient Strength | 500 mg/10mL |
| Pharm Classes | Macrolide Antimicrobial [EPC],Macrolides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2009-11-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA065501 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-11-09 |
| Ingredient | Strength |
|---|---|
| AZITHROMYCIN MONOHYDRATE | 500 mg/10mL |
| SPL SET ID: | 55051e03-b6dc-4bc6-87c1-e4fb84b61fa3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0904-6708 | azithromycin monohydrate | azithromycin monohydrate |
| 0904-6909 | azithromycin monohydrate | azithromycin monohydrate |
| 43063-713 | azithromycin monohydrate | azithromycin monohydrate |
| 43063-715 | azithromycin monohydrate | azithromycin monohydrate |
| 43063-728 | azithromycin monohydrate | azithromycin monohydrate |
| 48792-7869 | azithromycin monohydrate | azithromycin monohydrate |
| 48792-7870 | azithromycin monohydrate | azithromycin monohydrate |
| 50436-3136 | azithromycin monohydrate | azithromycin monohydrate |
| 68071-3187 | azithromycin monohydrate | azithromycin monohydrate |
| 68071-3168 | azithromycin monohydrate | azithromycin monohydrate |
| 68071-3136 | azithromycin monohydrate | azithromycin monohydrate |
| 68071-3169 | azithromycin monohydrate | azithromycin monohydrate |
| 68071-4214 | azithromycin monohydrate | azithromycin monohydrate |
| 68071-4230 | azithromycin monohydrate | azithromycin monohydrate |
| 68083-199 | Azithromycin monohydrate | Azithromycin monohydrate |
| 68180-160 | azithromycin monohydrate | azithromycin monohydrate |
| 68180-162 | azithromycin monohydrate | azithromycin monohydrate |
| 68180-161 | azithromycin monohydrate | azithromycin monohydrate |
| 69677-129 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 70518-0736 | azithromycin monohydrate | azithromycin monohydrate |
| 70518-0803 | azithromycin monohydrate | azithromycin monohydrate |
| 71205-119 | azithromycin monohydrate | azithromycin monohydrate |
| 53217-403 | azithromycin monohydrate | azithromycin monohydrate |
| 53217-327 | azithromycin monohydrate | azithromycin monohydrate |
| 55700-432 | azithromycin monohydrate | azithromycin monohydrate |
| 57297-160 | azithromycin monohydrate | azithromycin monohydrate |
| 57297-161 | azithromycin monohydrate | azithromycin monohydrate |
| 57297-162 | azithromycin monohydrate | azithromycin monohydrate |
| 60687-282 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 60687-271 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 60687-314 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 61919-096 | AZITHROMYCIN MONOHYDRATE | AZITHROMYCIN MONOHYDRATE |
| 61919-260 | AZITHROMYCIN MONOHYDRATE | AZITHROMYCIN MONOHYDRATE |
| 65162-760 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 65162-708 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 65162-758 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 65162-759 | Azithromycin Monohydrate | Azithromycin Monohydrate |
| 17478-307 | AzaSITE | Azithromycin Monohydrate |
| 0093-7148 | Azithromycin | Azithromycin Monohydrate |
| 0093-7149 | Azithromycin | Azithromycin Monohydrate |
| 0527-2370 | azithromycin | AZITHROMYCIN MONOHYDRATE |
| 0527-2381 | azithromycin | AZITHROMYCIN MONOHYDRATE |
| 0527-2395 | azithromycin | AZITHROMYCIN MONOHYDRATE |
| 21695-548 | Azithromycin | Azithromycin monohydrate |
| 21695-549 | Azithromycin | Azithromycin monohydrate |
| 48792-7871 | azithromycin | AZITHROMYCIN MONOHYDRATE |
| 51672-4200 | Azithromycin | AZITHROMYCIN MONOHYDRATE |