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NDC 00378-7503-32 BREYNA 160; 4.5 ug/1; ug/1 Details
BREYNA 160; 4.5 ug/1; ug/1
BREYNA is a RESPIRATORY (INHALATION) AEROSOL, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is BUDESONIDE; FORMOTEROL FUMARATE.
MedlinePlus Drug Summary
The combination of budesonide and formoterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma in adults and children 6 years of age and older. The combination of budesonide and formoterol is also used to treat chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema) in adults. Budesonide is in a class of medications called steroids. It works by reducing swelling in the airways. 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: 00378-7503-32Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Budesonide and Formoterol Oral Inhalation
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: 00378-7503-32Last Updated: 03/24/2024
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: 00378-7503-32Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Formoterol Oral Inhalation
Product Information
| NDC | 00378-7503 |
|---|---|
| Product ID | 0378-7503_4719c6e2-7ebe-43ee-9617-df57a6f4707c |
| Associated GPIs | |
| GCN Sequence Number | 062726 |
| GCN Sequence Number Description | budesonide/formoterol fumarate HFA AER AD 160-4.5MCG INHALATION |
| HIC3 | B63 |
| HIC3 Description | BETA-ADRENERGIC AND GLUCOCORTICOID COMBO, INHALED |
| GCN | 98500 |
| HICL Sequence Number | 021993 |
| HICL Sequence Number Description | BUDESONIDE/FORMOTEROL FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | BREYNA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Budesonide and Formoterol Fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | AEROSOL, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 160; 4.5 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | BUDESONIDE; FORMOTEROL FUMARATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211699 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-7503-32 (00378750332)
| NDC Package Code | 0378-7503-32 |
|---|---|
| Billing NDC | 00378750332 |
| Package | 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER |
| Marketing Start Date | 2023-07-31 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 23.7124 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | BREYNA 160-4.5 MCG INHALER |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |