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United States · US · US:50419-395_fd96ab4c-d7f4-446f-93d8-1dae246a450a
NUBEQA
Orange BookUNIISPLATC L02BB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL02BB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150419395011 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE
- ndc1150419395721 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
X05U0N2RCO
DAROLUTAMIDE
RxCUI 2180325
Orange Book
N212099
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X05U0N2RCO",
"rxcui": "2180325",
"inchikey": "BLIJXOOIHRSQRB-PXYINDEMSA-N",
"display_name": "DAROLUTAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1a7cb212-56e4-4b9d-a73d-bfee7fe4735e": {
"match": "brand_token",
"title": "NUBEQA (DAROLUTAMIDE) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "23",
"published_date": "2026-04-13"
}
},
"productid": "50419-395_fd96ab4c-d7f4-446f-93d8-1dae246a450a",
"productndc": "50419-395",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212099",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "300MG",
"product_no": "001",
"approval_date": "Jul 30, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAROLUTAMIDE",
"proprietary_name": "NUBEQA",
"active_ingred_unit": "mg/1",
"application_number": "NDA212099",
"marketing_category": "NDA",
"nonproprietary_name": "darolutamide",
"start_marketing_date": "20190731",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code L02BB06.
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