BREYNA

NDC 0378-7503 · Mylan Pharmaceuticals Inc.

Generic nameBudesonide and Formoterol Fumarate

Dosage formAEROSOL, METERED

RouteRESPIRATORY (INHALATION)

Active ingredient(s)BUDESONIDE, FORMOTEROL FUMARATE

Strength160; 4.5 ug/1; ug/1

Pharmacologic classAdrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]

Marketing categoryANDA

Packages

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

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0310-4600 — Glycopyrrolate and formoterol fumarate, 0310-4616 — budesonide, glycopyrrolate, and formoterol fumarate, 0310-6616 — budesonide, glycopyrrolate, and formoterol fumarate, 0310-7370 — Budesonide and Formoterol Fumarate Dihydrate, 0310-7372 — Budesonide and Formoterol Fumarate Dihydrate, 0310-9080 — Albuterol sulfate and budesonide, 0363-0048 — Budesonide, 0378-1631 — formoterol fumarate dihydrate, 0378-4500 — Budesonide, 0378-7502 — Budesonide and Formoterol Fumarate, 0480-3080 — Budesonide and formoterol fumarate dihydrate, 0480-3081 — Budesonide and formoterol fumarate dihydrate, 0487-9601 — BUDESONIDE, 0487-9701 — BUDESONIDE, 0536-1112 — Budesonide, 0536-1456 — Budesonide, 0574-9855 — budesonide, 0591-2510 — Budesonide, 0904-7313 — budesonide, 10122-120 — beclomethasone dipropionate/formoterol fumarate/glycopyrrolate, +92 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels