Bronchitol is a Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Mannitol.
| Product ID | 10122-212_159b4a7c-bc10-493f-9ead-e0b7f9563eef |
| NDC | 10122-212 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Bronchitol |
| Generic Name | Mannitol |
| Dosage Form | Capsule |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2021-02-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA202049 |
| Labeler Name | Chiesi USA, Inc. |
| Substance Name | MANNITOL |
| Active Ingredient Strength | 40 mg/1 |
| Pharm Classes | Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2021-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10122-212 | Bronchitol | mannitol |
| 67850-552 | Aridol Bronchial Challenge Test Kit | mannitol |
| 62171-100 | GD11 Rx SCM C5 | MANNITOL |
| 0264-2303 | Mannitol | Mannitol |
| 0264-7578 | Mannitol | MANNITOL |
| 0404-9905 | Mannitol | Mannitol |
| 0409-4031 | Mannitol | MANNITOL |
| 0409-7715 | Mannitol | MANNITOL |
| 0990-7715 | Mannitol | MANNITOL |
| 51662-1468 | MANNITOL | MANNITOL |
| 52584-031 | Mannitol | Mannitol |
| 63323-024 | Mannitol | MANNITOL |
| 0338-0351 | Osmitrol | Mannitol |
| 0338-0353 | Osmitrol | Mannitol |
| 0338-0355 | Osmitrol | Mannitol |
| 0338-0357 | Osmitrol | Mannitol |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BRONCHITOL 79012340 3107109 Live/Registered |
Pharmaxis Ltd 2005-06-01 |