Macitentan
- Product NDC
- 59651-147
- 11-digit product format
- 596510147
- Labeler code
- 59651
- Product ID
- 59651-147_861d338c-67ad-4725-87d9-b74d87b11a9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Macitentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA211198
- Marketing category
- ANDA
- Marketing start
- 2026-05-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Macitentan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MACITENTAN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z9K9Y9WMVL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-147-30 | Macitentan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-147-30 | 59651014730 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-147-30) | 2026-05-23 | No | No | Current |