OPSYNVI
- Product NDC
- 66215-812
- 11-digit product format
- 662150812
- Labeler code
- 66215
- Product ID
- 66215-812_32840e17-39b6-50b2-e063-6394a90a7a37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- macitentan and tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actelion Pharmaceuticals US, Inc.
- Application
- NDA218490
- Marketing category
- NDA
- Marketing start
- 2024-03-22
- Substance
- MACITENTAN; TADALAFIL
- Active strength
- 10; 20 mg/1; mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OPSYNVI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MACITENTAN | 10 mg/1 |
| TADALAFIL | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT, Z9K9Y9WMVL |
| Rxcui | 2677765, 2677771, 2677773, 2677775 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66215-812-01 | OPSYNVI | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 3 |
| 66215-812-07 | OPSYNVI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 66215-812-07 | OPSYNVI | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 3 |
| 66215-812-08 | OPSYNVI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 66215-812-30 | OPSYNVI | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 66215-812-30 | OPSYNVI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66215-812 | OPSYNVI (MACITENTAN AND TADALAFIL) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] | 3 | Current NDC, 6 package rows | 20250413_6945b183-18d3-40de-afd1-c88e33cc1a63.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 |
|---|
| 66215-812-01 | 66215081201 | 7 in 1 BLISTER PACK | | | | | Historical |
| 66215-812-07 | 66215081207 | 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-22 | No | No | Current |
| 66215-812-08 | 66215081208 | 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01) | 1 blister pack | 2024-03-22 | No | No | Current |
| 66215-812-30 | 66215081230 | 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-22 | No | No | Current |