United States · FDA National Drug Code directory
Bosentan
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
- 68382-447_6f108d08-40d2-4db6-a938-f6c3b54b3e02
- Product NDC
- 68382-447
- Form
- TABLET, COATED
- Composition / generic term
- Bosentan
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20190501
- Source listing expiry
- 20271231
Source-listed ingredients
- BOSENTAN — 125 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 100 TABLET, COATED in 1 BOTTLE (68382-447-01) · 68382-447-01
- 500 TABLET, COATED in 1 BOTTLE (68382-447-05) · 68382-447-05
- 60 TABLET, COATED in 1 BOTTLE (68382-447-14) · 68382-447-14
- 180 TABLET, COATED in 1 BOTTLE (68382-447-28) · 68382-447-28
- 10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30) · 68382-447-77
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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