TRYVIO
- Product NDC
- 80491-8012
- 11-digit product format
- 804918012
- Labeler code
- 80491
- Product ID
- 80491-8012_68b78342-ced1-436d-b591-bb14e1a9a2f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aprocitentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Idorsia Pharmaceuticals Ltd
- Application
- NDA217686
- Marketing category
- NDA
- Marketing start
- 2024-03-20
- Substance
- APROCITENTAN
- Active strength
- 12.5 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
- TRYVIO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APROCITENTAN | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MZI81HV01P |
| Rxcui | 2679064, 2679070 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80491-8012-3 | TRYVIO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
| 80491-8012-3 | TRYVIO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 80491-8012-7 | TRYVIO | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
| 80491-8012-8 | TRYVIO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80491-8012 | TRYVIO (APROCITENTAN) TABLET, FILM COATED [IDORSIA PHARMACEUTICALS LTD] | 6 | Current NDC, 4 package rows | 20250417_dfe7a2ee-612c-4aba-834a-d68e6b59a0a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80491-8012-3 | 80491801203 | 1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-10-01 | No | No | Historical |
| 80491-8012-7 | 80491801207 | 10 in 1 BLISTER PACK | | | | | Historical |
| 80491-8012-8 | 80491801208 | 1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7) | 1 blister pack | 2024-03-20 | No | No | Historical |