NDC product

Budesonide

NDC 0378-4500 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-4500
Proprietary name Budesonide
Nonproprietary name Budesonide
Substances BUDESONIDE
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA208851
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
Marketing start Oct 21, 2020
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

Browse all National Drug Codes (NDC)