| NDC Code | 0310-4616-39 |
| Package Description | 28 AEROSOL, METERED in 1 INHALER (0310-4616-39) |
| Product NDC | 0310-4616 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Breztri |
| Non-Proprietary Name | Budesonide, Glycopyrrolate, And Formoterol Fumarate |
| Dosage Form | AEROSOL, METERED |
| Usage | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20200723 |
| Marketing Category Name | NDA |
| Application Number | NDA212122 |
| Manufacturer | AstraZeneca Pharmaceuticals LP |
| Substance Name | BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
| Strength | 160; 4.8; 9 |
| Strength Unit | ug/1; ug/1; ug/1 |
| Pharmacy Classes | Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |