NDC 82584-307
AZASITE
Azithromycin Monohydrate
AZASITE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Thea Pharma Inc.. The primary component is Azithromycin Monohydrate.
| Product ID | 82584-307_e6d61d75-84a0-0f8e-e053-2a95a90a2f19 |
| NDC | 82584-307 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AZASITE |
| Generic Name | Azithromycin Monohydrate |
| Dosage Form | Solution/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2022-11-01 |
| Marketing Category | NDA / |
| Application Number | NDA050810 |
| Labeler Name | Thea Pharma Inc. |
| Substance Name | AZITHROMYCIN MONOHYDRATE |
| Active Ingredient Strength | 10 mg/mL |
| Pharm Classes | Macrolide Antimicrobial [EPC], Macrolides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 82584-307-02
1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) > 2.5 mL in 1 BOTTLE, DROPPER
| Marketing Start Date | 2022-11-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "AZASITE" or generic name "Azithromycin Monohydrate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 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 |
| 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 |
Trademark Results [AZASITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AZASITE 78426374 3345071 Live/Registered |
INSITE VISION INCORPORATED 2004-05-27 |
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