🇺🇸
United States · US · US:72769-114_30d087b8-4328-4ec8-bc73-f15bdd7fe7c0
Orladeyo
Orange BookUNIISPLATC B06AC06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBioCryst Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeB06AC06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172769114024 DOSE PACK in 1 CARTON (72769-114-02) / 7 PACKET in 1 DOSE PACK / 22 PELLET in 1 PACKET
Annotations
UNII (FDA Substance ID)
88SH1NBL2B
BEROTRALSTAT HYDROCHLORIDE
RxCUI 2467541
Orange Book
N219776
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "88SH1NBL2B",
"rxcui": "2467541",
"inchikey": "XFZLBLTUANGZBD-QDSLRZTOSA-N",
"display_name": "BEROTRALSTAT HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3527ece1-e7e0-40b1-b0c5-6baeb0deabeb": {
"match": "brand_token",
"title": "ORLADEYO (BEROTRALSTAT HYDROCHLORIDE) CAPSULE ORLADEYO (BEROTRALSTAT HYDROCHLORIDE) PELLET [BIOCRYST PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2026-02-18"
}
},
"productid": "72769-114_30d087b8-4328-4ec8-bc73-f15bdd7fe7c0",
"productndc": "72769-114",
"dosage_form": "PELLET",
"orange_book": {
"appl_no": "219776",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 72MG BASE/PACKET",
"product_no": "001",
"approval_date": "Dec 11, 2025"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 96MG BASE/PACKET",
"product_no": "002",
"approval_date": "Dec 11, 2025"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 108MG BASE/PACKET",
"product_no": "003",
"approval_date": "Dec 11, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 132MG BASE/PACKET",
"product_no": "004",
"approval_date": "Dec 11, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BEROTRALSTAT HYDROCHLORIDE",
"proprietary_name": "Orladeyo",
"active_ingred_unit": "mg/1",
"application_number": "NDA219776",
"marketing_category": "NDA",
"nonproprietary_name": "Berotralstat hydrochloride",
"start_marketing_date": "20201204",
"active_numerator_strength": "132"
}Related drugs
Other records sharing ATC code B06AC06.
Access this data programmatically
Query Orladeyo and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.