Home NDC 66215-814 OPSYNVI
Product NDC 66215-814
11-digit product format 662150814
Labeler code 66215
Product ID 66215-814_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; 40 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218490-001 OPSYNVI MACITENTAN; TADALAFIL 10MG;20MG TABLET / ORAL RLD 2024-03-22 N218490-002 OPSYNVI MACITENTAN; TADALAFIL 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 N218490-001 7094781*PED 2026-06-05 Pediatric extension N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 N218490-001 10946015*PED 2027-03-11 Pediatric extension N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 N218490-001 8268847*PED 2029-10-18 Pediatric extension N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 N218490-002 7094781*PED 2026-06-05 Pediatric extension N218490-002 10946015 2026-09-11 U-3881 Drug product 2024-04-18 N218490-002 10946015*PED 2027-03-11 Pediatric extension N218490-002 8268847 2029-04-18 U-3882 Drug product 2024-04-18 N218490-002 8268847*PED 2029-10-18 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 120 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-001 7094781*PED 2026-06-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-001 10946015*PED 2027-03-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-001 8268847*PED 2029-10-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 7094781*PED 2026-06-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 10946015 2026-09-11 U-3881 Drug product 2024-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 10946015*PED 2027-03-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 8268847 2029-04-18 U-3882 Drug product 2024-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218490-002 8268847*PED 2029-10-18 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-001 7094781*PED 2026-06-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-001 10946015*PED 2027-03-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-001 8268847*PED 2029-10-18 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 7094781*PED 2026-06-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 10946015 2026-09-11 U-3881 Drug product 2024-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 10946015*PED 2027-03-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 8268847 2029-04-18 U-3882 Drug product 2024-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218490-002 8268847*PED 2029-10-18 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 7094781*PED 2026-06-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 10946015*PED 2027-03-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-001 8268847*PED 2029-10-18 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 7094781*PED 2026-06-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 10946015 2026-09-11 U-3881 Drug product 2024-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 10946015*PED 2027-03-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 8268847 2029-04-18 U-3882 Drug product 2024-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218490-002 8268847*PED 2029-10-18 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 80 observed states.
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 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z9K9Y9WMVL Internal UNII lookup 742SXX0ICT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2677765 Internal RxNorm lookup 2677771 Internal RxNorm lookup 2677773 Internal RxNorm lookup 2677775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66215-814-01 OPSYNVI 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 66215-814-10 OPSYNVI 1 in 1 CARTON TABLET, FILM COATED 1 3 66215-814-30 OPSYNVI 1 in 1 CARTON TABLET, FILM COATED 1 3 66215-814-30 OPSYNVI 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-814 OPSYNVI (MACITENTAN AND TADALAFIL) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 3 Current NDC, 4 package rows 20250413_6945b183-18d3-40de-afd1-c88e33cc1a63.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OPSYNVI MACITENTAN AND TADALAFIL Actelion Pharmaceuticals US, Inc. 6945b183-18d3-40de-afd1-c88e33cc1a63 2025-04-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218490 application number: NDA218490 ndc (product): 66215-814
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66215-814-01 66215081401 10 in 1 BLISTER PACK Historical 66215-814-10 66215081410 1 BLISTER PACK in 1 CARTON (66215-814-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (66215-814-01) 1 blister pack 2024-03-22 No No Current 66215-814-30 66215081430 1 BOTTLE in 1 CARTON (66215-814-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-03-22 No No Current