MACITENTAN
- Product NDC
- 70710-1166
- 11-digit product format
- 707101166
- Labeler code
- 70710
- Product ID
- 70710-1166_a5723ac2-5bfa-4270-9268-6a6533a841f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MACITENTAN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA211224
- Marketing category
- ANDA
- Marketing start
- 2025-11-05
- Substance
- MACITENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|
| 70710-1166-3 | 70710116603 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1166-3) | | 2025-11-05 | No | No | Historical |
| 70710-1166-5 | 70710116605 | 5 BLISTER PACK in 1 CARTON (70710-1166-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4) | 5 blister pack | 2025-11-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| MACITENTAN | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Umedica Laboratories Pvt Ltd | 2026-05-20 | HUMAN PRESCRIPTION DRUG LABEL | 6 |