Budesonide

NDC 0378-4500 · Mylan Pharmaceuticals Inc.

Generic nameBudesonide

Dosage formTABLET, FILM COATED, EXTENDED RELEASE

RouteORAL

Active ingredient(s)BUDESONIDE

Strength9 mg/1

Pharmacologic classCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]

Marketing categoryANDA

Packages

0378-4500-93 — 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0186-0372 — Budesonide and Formoterol Fumarate Dihydrate, 0186-1988 — Budesonide, 0186-1989 — Budesonide, 0186-1990 — Budesonide, 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, 0378-7502 — Budesonide and Formoterol Fumarate, 0378-7503 — 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, +69 more

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.