United States · FDA National Drug Code directory
Roflumilast
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
- 0904-7399_44dcecac-a91b-4149-b030-d44e925bee4b
- Product NDC
- 0904-7399
- Form
- TABLET
- Composition / generic term
- Roflumilast
- Labeler
- MAJOR PHARMACEUTICALS
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20231226
- Source listing expiry
- 20261231
Source-listed ingredients
- ROFLUMILAST — 500 ug/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 TABLET in 1 BOTTLE (0904-7399-46) · 0904-7399-46
- 90 TABLET in 1 BOTTLE (0904-7399-89) · 0904-7399-89
Source and coverage
Open FDA National Drug Code directory →
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.
Browse United States records →