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NDC 00310-4616-28 BREZTRI 160; 4.8; 9 ug/1; ug/1; ug/1 Details
BREZTRI 160; 4.8; 9 ug/1; ug/1; ug/1
BREZTRI is a RESPIRATORY (INHALATION) AEROSOL, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE.
MedlinePlus Drug Summary
Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age. Budesonide belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.
Related Packages: 00310-4616-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Budesonide Oral Inhalation
Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 00310-4616-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Formoterol Oral Inhalation
Glycopyrrolate oral inhalation is used as a long term treatment to control wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Glycopyrrolate is in a class of medications called anticholinergics. It works by relaxing the muscles around the airways in your lungs, making it easier to breathe.
Related Packages: 00310-4616-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Glycopyrrolate Oral Inhalation
Product Information
| NDC | 00310-4616 |
|---|---|
| Product ID | 0310-4616_650ce9da-73d0-4335-b8f4-dabb12672108 |
| Associated GPIs | 44209903303220 |
| GCN Sequence Number | 081351 |
| GCN Sequence Number Description | budesonide/glycopyr/formoterol HFA AER AD 160-9-4.8 INHALATION |
| HIC3 | B64 |
| HIC3 Description | BETA-ADRENERGIC-ANTICHOLINERGIC-GLUCOCORT, INHALED |
| GCN | 48435 |
| HICL Sequence Number | 046753 |
| HICL Sequence Number Description | BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE |
| Brand/Generic | Brand |
| Proprietary Name | BREZTRI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | budesonide, glycopyrrolate, and formoterol fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | AEROSOL, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 160; 4.8; 9 |
| Active Ingredient Units | ug/1; ug/1; ug/1 |
| Substance Name | BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212122 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-4616-28 (00310461628)
| NDC Package Code | 0310-4616-28 |
|---|---|
| Billing NDC | 00310461628 |
| Package | 28 AEROSOL, METERED in 1 INHALER (0310-4616-28) |
| Marketing Start Date | 2020-07-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |