macitentan
- Product NDC
- 0781-8135
- 11-digit product format
- 007818135
- Labeler code
- 0781
- Product ID
- 0781-8135_91232484-55b7-47dc-bc30-e63a6b469df6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- macitentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA211136
- Marketing category
- ANDA
- Marketing start
- 2025-08-20
- 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 |
| Rxcui | 1442137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-8135-31 | 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 | Status |
|---|
| 0781-8135-31 | 00781813531 | 30 in 1 BOTTLE | Historical |