🇺🇸
United States · US · US:72578-148_de3be678-a82f-4052-b7ce-728d887d548e
Darunavir
Orange BookUNIISPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117257814805500 TABLET, FILM COATED in 1 BOTTLE (72578-148-05)
- ndc11725781480630 TABLET, FILM COATED in 1 BOTTLE (72578-148-06)
- ndc11725781481690 TABLET, FILM COATED in 1 BOTTLE (72578-148-16)
Annotations
UNII (FDA Substance ID)
YO603Y8113
DARUNAVIR
RxCUI 460132
Orange Book
A214085
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YO603Y8113",
"rxcui": "460132",
"inchikey": "CJBJHOAVZSMMDJ-HEXNFIEUSA-N",
"display_name": "DARUNAVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e80e44f8-1987-4b78-a63d-a4e4d5122ddb": {
"match": "brand_token",
"title": "DARUNAVIR TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "100",
"published_date": "2026-03-12"
}
},
"productid": "72578-148_de3be678-a82f-4052-b7ce-728d887d548e",
"productndc": "72578-148",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214085",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Dec 13, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Dec 13, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DARUNAVIR",
"proprietary_name": "Darunavir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214085",
"marketing_category": "ANDA",
"nonproprietary_name": "Darunavir",
"start_marketing_date": "20240501",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code J05AE10.
Access this data programmatically
Query Darunavir 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.