United States · FDA National Drug Code directory
Budesonide
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
- 0378-4500_812acf8d-0936-4ba9-9952-ae9f2266649b
- Product NDC
- 0378-4500
- Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Composition / generic term
- Budesonide
- Labeler
- Mylan Pharmaceuticals Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20201021
- Source listing expiry
- 20261231
Source-listed ingredients
- BUDESONIDE — 9 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93) · 0378-4500-93
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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