FDA.reportPublic FDA data

ambrisentan 5 MG Oral Tablet

RxCUI
722122
RxNorm name
ambrisentan 5 MG Oral Tablet
Display name
ambrisentan 5 MG Oral Tablet
Full name
ambrisentan 5 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmbrisentanAMBRISENTANZydus Pharmaceuticals USA Inc.37af3191-0ed3-4783-8747-065f1462f2d22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
LetairisAMBRISENTANGilead Sciences, Inc.725d4e73-6c83-477a-adc6-0ae4a133a8442026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANGolden State Medical Supply, Inc.4396bab5-2851-62ef-e063-6294a90af76e2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANQuallent Pharmaceuticals Health LLC6fc6032f-94dc-4067-8b24-01990ec99db02026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANMylan Pharmaceuticals Inc.8080b009-361b-4505-b09a-0d91a0e4a2c02025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANApotex Corp.291a782a-77e1-8a8e-e1c8-2626f305c2b72025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
ambrisentanAMBRISENTANA-S Medication Solutionsfda3e8b5-267b-4690-85c2-78626986245c2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANActavis Pharma, Inc.32549c43-f8ff-422c-b42d-ca0877e661cf2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
ambrisentanAMBRISENTANSun Pharmaceutical Industries, Inc.a4978a54-1799-43d6-85dd-05fa9de0a5d72025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANCipla USA Inc.0e418384-cae1-47ae-ac5e-afc845d694f62025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
ambrisentanAMBRISENTANAurobindo Pharma Limited82e51c75-fb78-4ad3-8bce-5e0581d600142025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122
AmbrisentanAMBRISENTANZydus Lifesciences Limited0e3e3320-27ac-404f-9f01-3d82696e768a2024-11-25Exact identifier
rxcui: 722122
AMBRISENTANAMBRISENTANSigmapharm Laboratories, LLCe20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac2023-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 722122

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 13 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
725d4e73-6c83-477a-adc6-0ae4a133a844ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]227These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 200720250822
32549c43-f8ff-422c-b42d-ca0877e661cfambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]219These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS . AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720250530
37af3191-0ed3-4783-8747-065f1462f2d2ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720250415
0e3e3320-27ac-404f-9f01-3d82696e768aambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]210AMBRISENTAN Tablets20241125
291a782a-77e1-8a8e-e1c8-2626f305c2b7ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS . AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720251118
a4978a54-1799-43d6-85dd-05fa9de0a5d7ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720250430
0e418384-cae1-47ae-ac5e-afc845d694f6ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720250422
8080b009-361b-4505-b09a-0d91a0e4a2c0ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720251205
e20ab2fe-bc9f-48a3-b15a-e4bc9532c2acambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN Tablets, for oral use Initial U.S. Approval: 200720230110
6fc6032f-94dc-4067-8b24-01990ec99db0ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720260105
4396bab5-2851-62ef-e063-6294a90af76eambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]23AMBRISENTAN TABLETS. These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720260127
82e51c75-fb78-4ad3-8bce-5e0581d60014ambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720250421
fda3e8b5-267b-4690-85c2-78626986245cambrisentan 5 MG Oral Tablet [PSN] · ambrisentan 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral use Initial U.S. Approval: 200720251008