United States · FDA National Drug Code directory

BREYNA

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
0378-7503_c9fc3541-8929-4517-9a4e-969fca81e390
Product NDC
0378-7503
Form
AEROSOL, METERED
Composition / generic term
Budesonide and Formoterol Fumarate
Labeler
Mylan Pharmaceuticals Inc.
Marketing category
ANDA
Marketing start / end (source format)
20230731
Source listing expiry
20271231

Source-listed ingredients

  • BUDESONIDE — 160 ug/1
  • FORMOTEROL FUMARATE — 4.5 ug/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER · 0378-7503-32

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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