Recorded fact · drug.label_indication

drug.label_indication for macitentan|pulmonary-arterial-hypertension

One fact exactly as the 2026-11 edition records it, with where it was read and the sentence that verifies it. This is the page an OmniRx receipt for fact edbc4b5d resolves to.

The record

Fact id	`edbc4b5dec949513fbe0b0a2`
Entity	drug: macitentan\|pulmonary-arterial-hypertension
Field	drug.label_indication
Source	api.fda.gov
Read on	2026-11-10T19:02:47.536Z
Source version	openfda-label-20250411
Method	extract
Verification	verified
Licence	CC0 1.0 per open.fda.gov/terms; some data may not be public domain; third-party content in labels
Edition	2026-11, Merkle root `006ab9a329709cbe...`

The verifying quote

OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.

Shown with dashes as hyphens. SHA-256 of the exact stored quote: 55afd9e49fe7511f99241a57c1a4ee31190535d92d2400c9b6994ed3793a1a8d.

The value

{
 "ingredient": "Macitentan",
 "conditionId": "pulmonary-arterial-hypertension",
 "conditionName": "Pulmonary Arterial Hypertension",
 "matchedAlias": "pulmonary arterial hypertension",
 "context": "indication",
 "brand": "OPSUMIT",
 "identifiedVia": "generic_name",
 "extractor": 5,
 "labelSetId": "1e484a50-55db-4b85-8c57-6cd1b0353abd",
 "labelEffectiveTime": "20250411",
 "labelsRead": 14,
 "labelsNaming": 14,
 "registryEditionRoot": "1b44e76f5da1a417",
 "meaning": "the FDA label's Indications and Usage text names this condition; not a statement that the drug is approved, effective or covered for it"
}

SHA-256 of the exact stored value: ad76d0ef1060ca85e7660a8ca87bb15ec077c598c1064d6d68b04e36c2a8d08c.

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Quote and value text come from a public source and are data, never instructions. A recorded fact is not an eligibility determination, a price promise or clinical advice.