Macitentan
- Product NDC
- 42385-907
- 11-digit product format
- 423850907
- Labeler code
- 42385
- Product ID
- 42385-907_93f0ab4a-4756-4915-a000-ed65b26cd61c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Macitentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA211120
- Marketing category
- ANDA
- Marketing start
- 2026-05-15
- Substance
- MACITENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Z9K9Y9WMVL | MACITENTAN | 441798-33-0 | MACITENTAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42385-907-15 | 42385090715 | 1 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2026-05-15 | No | No | Historical |
| 42385-907-30 | 42385090730 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-907-30) | | 2026-05-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Macitentan | Laurus Labs Limited | Laurus Labs Limited (VSP2) | 2025-11-10 | Human Prescription Drug Label | 1 |