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
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 |
|---|
| 70710-1166-3 | MACITENTAN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 70710-1166-4 | MACITENTAN | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 6 |
| 70710-1166-5 | MACITENTAN | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 70710-1166-4 | 70710116604 | 3 in 1 BLISTER PACK | | | | | 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 | Current |