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
- 42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fc
- Product NDC
- 42571-369
- Form
- TABLET
- Composition / generic term
- ROFLUMILAST
- Labeler
- Micro Labs Limited
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20230501
- Source listing expiry
- 20261231
Source-listed ingredients
- ROFLUMILAST — 250 ug/1
These values do not establish equivalence or a dose recommendation.
Packages
- 500 TABLET in 1 BOTTLE (42571-369-05) · 42571-369-05
- 10 BLISTER PACK in 1 CARTON (42571-369-11) / 10 TABLET in 1 BLISTER PACK (42571-369-32) · 42571-369-11
- 30 TABLET in 1 BOTTLE (42571-369-30) · 42571-369-30
- 28 TABLET in 1 BOTTLE (42571-369-83) · 42571-369-83
- 90 TABLET in 1 BOTTLE (42571-369-90) · 42571-369-90
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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