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United States · US · US:74528-020_3a4fbe0a-d2a7-419f-a1d5-966cda1d7580
BYLVAY
Orange BookUNIISPLATC A05AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlbireo Pharma, Inc.
CountryUS (United States)
ATC codeA05AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1174528020011 BOTTLE in 1 CARTON (74528-020-01) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2W150K0UUC
ODEVIXIBAT
RxCUI 2563966
Orange Book
N215498
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2W150K0UUC",
"rxcui": "2563966",
"inchikey": "XULSCZPZVQIMFM-IPZQJPLYSA-N",
"display_name": "ODEVIXIBAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"151f1d3e-2bf4-47ce-b1be-a892de3258fa": {
"match": "brand_token",
"title": "BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS [ALBIREO PHARMA, INC.]",
"spl_version": "9",
"published_date": "2026-02-16"
}
},
"productid": "74528-020_3a4fbe0a-d2a7-419f-a1d5-966cda1d7580",
"productndc": "74528-020",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "215498",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.2MG",
"product_no": "001",
"approval_date": "Jul 20, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.4MG",
"product_no": "002",
"approval_date": "Jul 20, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.6MG",
"product_no": "003",
"approval_date": "Jul 20, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.2MG",
"product_no": "004",
"approval_date": "Jul 20, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ODEVIXIBAT",
"proprietary_name": "BYLVAY",
"active_ingred_unit": "ug/1",
"application_number": "NDA215498",
"marketing_category": "NDA",
"nonproprietary_name": "odevixibat",
"start_marketing_date": "20210720",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code A05AX05.
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