FDA.reportPublic FDA data

macitentan 10 MG Oral Tablet

RxCUI
1442137
RxNorm name
macitentan 10 MG Oral Tablet
Display name
macitentan 10 MG Oral Tablet
Full name
macitentan 10 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
macitentanMACITENTANApotex Corp.226049ba-9c76-0798-6725-ee027a0418202026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANAurobindo Pharma Limited88b9f3b0-3f8f-47e4-bbd7-a2a785ed4ac02026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANAlembic Pharmaceuticals Limited4d9d9a84-6853-4004-b20a-8849b34453a42026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANAlembic Pharmaceuticals Inc.98b3309a-5012-42b5-b773-a38c2f52296c2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MACITENTANMACITENTANZydus Pharmaceuticals USA Inc.39ed1c20-99ae-4780-b040-dbebfc90018f2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANTorrent Pharmaceuticals Limitedfbfae088-44e6-4296-81d1-c2b6eecacc812026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANNovugen Pharma (USA) LLC8cabe7dd-1592-4764-a48a-f086288cae612026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
macitentanMACITENTANSandoz Inc91232484-55b7-47dc-bc30-e63a6b469df62026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANLaurus Labs Limited93f0ab4a-4756-4915-a000-ed65b26cd61c2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANMylan Pharmaceuticals Inc.d88a13e7-cf08-4632-86be-dcd9795162962025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANSun Pharmaceutical Industries, Inc.8de5c74f-b172-4485-a3f0-95e0172299d82025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
macitentanMACITENTANTeva Pharmaceuticals, Inc.b196010f-2ba2-4fa7-8e19-a58000a9563d2025-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
MacitentanMACITENTANAmneal Pharmaceuticals NY LLCe153997b-7b61-4737-97bd-ff8be3c097952025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137
OPSUMITMACITENTANActelion Pharmaceuticals US, Inc.1e484a50-55db-4b85-8c57-6cd1b0353abd2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1442137

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1e484a50-55db-4b85-8c57-6cd1b0353abdmacitentan 10 MG Oral TabletPSN35These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT ® (macitentan) tablets, for oral use Initial U.S. Approval: 201320250411
1e484a50-55db-4b85-8c57-6cd1b0353abdmacitentan 10 MG Oral TabletSCD35These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT ® (macitentan) tablets, for oral use Initial U.S. Approval: 201320250411
39ed1c20-99ae-4780-b040-dbebfc90018fmacitentan 10 MG Oral TabletSCD6These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260520
39ed1c20-99ae-4780-b040-dbebfc90018fmacitentan 10 MG Oral TabletPSN6These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260520
88b9f3b0-3f8f-47e4-bbd7-a2a785ed4ac0macitentan 10 MG Oral TabletSCD6These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260429
88b9f3b0-3f8f-47e4-bbd7-a2a785ed4ac0macitentan 10 MG Oral TabletPSN6These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260429
8cabe7dd-1592-4764-a48a-f086288cae61macitentan 10 MG Oral TabletPSN1These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260505
8cabe7dd-1592-4764-a48a-f086288cae61macitentan 10 MG Oral TabletSCD1These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260505
91232484-55b7-47dc-bc30-e63a6b469df6macitentan 10 MG Oral TabletPSN1These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260406
91232484-55b7-47dc-bc30-e63a6b469df6macitentan 10 MG Oral TabletSCD1These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320260406
93f0ab4a-4756-4915-a000-ed65b26cd61cmacitentan 10 MG Oral TabletSCD1These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320251110
93f0ab4a-4756-4915-a000-ed65b26cd61cmacitentan 10 MG Oral TabletPSN1These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 201320251110