Product Information
BREYNA 80-4.5 MCG INHALER is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $18.5368 per GM under NDC 00378750232. Its NADAC has been published 155 times since Oct 18, 2023.
FDA first approved this application on Mar 15, 2022. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
80; 4.5 ug/1; ug/1
Manufacturer
Mylan Pharmaceuticals Inc.NDC
00378750232
Classification
Generic
Dosage Form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Effective Date
9/23/2026
Active Ingredients
BUDESONIDE; FORMOTEROL FUMARATEApproval Type
Generic (ANDA)
FDA Application
ANDA211699FDA Approved
3/15/2022
TE Code
AB
On Market Since
7/31/2023
Pharmacological Classes
Price Statistics
The NADAC for BREYNA 80-4.5 MCG INHALER has been published 155 times since Oct 18, 2023, and over the history we have for it it has declined 8.2%. The table below summarizes its recorded NADAC range and movement.
| Current price | $18.5368 per GM |
|---|---|
| All-time high | $21.1528 (Feb 14, 2024) |
| All-time low | $14.3738 (May 22, 2024) |
| 52-week high | $20.6000 |
| 52-week low | $18.5368 |
| Median price | $20.2330 |
| Average price | $19.8464 |
| Largest weekly change | +39.1% (Jun 19, 2024) |
| Weeks tracked | 155 |
| Tracking since | Oct 18, 2023 |
Generic Alternatives
No other NADAC-published product shares this drug's active ingredient and strength in a comparable dosage form. Compare the broader picture on the Budesonide and Formoterol Fumarate market page.
Lowest-Cost Alternatives
No alternatives available
Related Drugs
Same classification
Continue researching this drug
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Manufacturer
Mylan Pharmaceuticals Inc. manufacturer profile
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Drug market
Budesonide and Formoterol Fumarate market comparison
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Therapeutic class
Corticosteroid class view
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
Frequently asked questions
What is the NADAC price of BREYNA 80-4.5 MCG INHALER?
The current National Average Drug Acquisition Cost (NADAC) for BREYNA 80-4.5 MCG INHALER, manufactured by Mylan Pharmaceuticals Inc., is $18.5368 per GM (NDC 00378750232), effective Sep 30, 2026.
How has the price of BREYNA 80-4.5 MCG INHALER changed over time?
Over the history we have for it, the NADAC for BREYNA 80-4.5 MCG INHALER has declined 8.2%. It has been tracked across 155 weekly CMS publications since Oct 18, 2023.
What are the highest and lowest recorded NADAC prices for BREYNA 80-4.5 MCG INHALER?
Since Oct 18, 2023, the NADAC for BREYNA 80-4.5 MCG INHALER has ranged from a low of $14.3738 (May 22, 2024) to a high of $21.1528 (Feb 14, 2024), with a median of $20.2330 per GM.
Are there cheaper alternatives to BREYNA 80-4.5 MCG INHALER?
No other NADAC-published product currently shares the active ingredient and strength of BREYNA 80-4.5 MCG INHALER in a comparable dosage form, so no direct lower-cost alternative is listed.
Who manufactures BREYNA 80-4.5 MCG INHALER?
BREYNA 80-4.5 MCG INHALER (NDC 00378750232) is labeled by Mylan Pharmaceuticals Inc., and CMS classifies it as a generic product.