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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Macitentan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MACITENTAN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z9K9Y9WMVL |
| Rxcui | 1442137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-907-15 | Macitentan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 42385-907-15 | Macitentan | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 42385-907-30 | Macitentan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 42385-907-30 | 42385090730 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-907-30) | | 2026-05-15 | No | No | Current |