FDA.reportPublic FDA data

Ambrisentan

Manufacturer
Veranova, L.P.
Effective date
2026-01-06
Label type
BULK INGREDIENT
Version
7
Source
full-release
Hydrated at
2026-06-01 02:52:17

Label at a glance#

ProductAmbrisentan
Active ingredientAMBRISENTAN
Label structure1 sections

Label contents#

Full prescribing information#

Ambrisentan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ambrisentan_LabelAmbrisentan_Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AMBRISENTAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7db2b61-402f-f2c9-6e9c-10d81037d0baProduct name320230126

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50137-4051-12021-12-16C16284748780-1ba0f9c33-5d45-a910-e053-dadaa90a0b85Ambrisentan (4051.F)
50137-4051-12021-01-29C16284748780-1ba0f9c33-5d45-a910-e053-dadaa90a0b85Ambrisentan (4051.F)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50137-4051-1Ambrisentan1 kg in 1 CONTAINERPOWDER17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50137-405150137-4051-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMBRISENTANHW6NV07QECACTIB

Source Document#

Source XML

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
AmbrisentanAMBRISENTANApotex Corp.291a782a-77e1-8a8e-e1c8-2626f305c2b72026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANZydus Pharmaceuticals USA Inc.37af3191-0ed3-4783-8747-065f1462f2d22026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
LetairisAMBRISENTANGilead Sciences, Inc.725d4e73-6c83-477a-adc6-0ae4a133a8442026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANGolden State Medical Supply, Inc.4396bab5-2851-62ef-e063-6294a90af76e2026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANQuallent Pharmaceuticals Health LLC6fc6032f-94dc-4067-8b24-01990ec99db02026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANMylan Pharmaceuticals Inc.8080b009-361b-4505-b09a-0d91a0e4a2c02025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
ambrisentanAMBRISENTANA-S Medication Solutionsa7dcdea4-d3da-4dc1-9193-6ebdb5b4e6902025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ambrisentan
generic name: AMBRISENTAN
ambrisentanAMBRISENTANA-S Medication Solutionsfda3e8b5-267b-4690-85c2-78626986245c2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ambrisentan
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANActavis Pharma, Inc.32549c43-f8ff-422c-b42d-ca0877e661cf2025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
ambrisentanAMBRISENTANSun Pharmaceutical Industries, Inc.a4978a54-1799-43d6-85dd-05fa9de0a5d72025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ambrisentan
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANCipla USA Inc.0e418384-cae1-47ae-ac5e-afc845d694f62025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
ambrisentanAMBRISENTANAurobindo Pharma Limited82e51c75-fb78-4ad3-8bce-5e0581d600142025-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ambrisentan
generic name: AMBRISENTAN
AmbrisentanAMBRISENTANZydus Lifesciences Limited0e3e3320-27ac-404f-9f01-3d82696e768a2024-11-25Name fallback
brand name: Ambrisentan
generic name: AMBRISENTAN
AMBRISENTANAMBRISENTANSigmapharm Laboratories, LLCe20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac2023-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMBRISENTAN
generic name: AMBRISENTAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.