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United States · US · US:72769-101_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
- ndc1172769101014 DOSE PACK in 1 CARTON (72769-101-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
88SH1NBL2B
BEROTRALSTAT HYDROCHLORIDE
RxCUI 2467541
Orange Book
N214094
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": "72769-101_30d087b8-4328-4ec8-bc73-f15bdd7fe7c0",
"productndc": "72769-101",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "214094",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 110MG BASE",
"product_no": "001",
"approval_date": "Dec 3, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Dec 3, 2020"
}
],
"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": "NDA214094",
"marketing_category": "NDA",
"nonproprietary_name": "Berotralstat hydrochloride",
"start_marketing_date": "20201204",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code B06AC06.
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