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
- 68382-624_70642eb6-1ced-4f90-85b2-7d4238c197d0
- Product NDC
- 68382-624
- Form
- TABLET
- Composition / generic term
- Roflumilast
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20230518
- Source listing expiry
- 20261231
Source-listed ingredients
- ROFLUMILAST — 250 ug/1
These values do not establish equivalence or a dose recommendation.
Packages
- 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK · 68382-624-31
- 2 BLISTER PACK in 1 CARTON (68382-624-83) / 10 TABLET in 1 BLISTER PACK (68382-624-30) · 68382-624-83
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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