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United States · US · US:71558-001_43046e5b-e40b-423d-a98d-a2fecc2cbd2e
Brinsupri
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInsmed Incorporated
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11715580013030 TABLET in 1 BOTTLE (71558-001-30)
Annotations
UNII (FDA Substance ID)
25CG88L0BB
BRENSOCATIB
Orange Book
N217673
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "25CG88L0BB",
"rxcui": null,
"inchikey": "AEXFXNFMSAAELR-RXVVDRJESA-N",
"display_name": "BRENSOCATIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b56986ae-e7db-421e-b622-a7f41e321f3d": {
"match": "brand_token",
"title": "BRINSUPRI (BRENSOCATIB) TABLET [INSMED INCORPORATED]",
"spl_version": "3",
"published_date": "2026-03-24"
}
},
"productid": "71558-001_43046e5b-e40b-423d-a98d-a2fecc2cbd2e",
"productndc": "71558-001",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217673",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 12, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 12, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRENSOCATIB",
"proprietary_name": "Brinsupri",
"active_ingred_unit": "mg/1",
"application_number": "NDA217673",
"marketing_category": "NDA",
"nonproprietary_name": "Brensocatib",
"start_marketing_date": "20250812",
"active_numerator_strength": "10"
}Access this data programmatically
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