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United States · US · US:71335-2611_585d2da0-738a-48d3-8995-bdb8959a0193
Darunavir
Orange BookUNIISPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11713352611115 TABLET, FILM COATED in 1 BOTTLE (71335-2611-1)
Annotations
UNII (FDA Substance ID)
YO603Y8113
DARUNAVIR
RxCUI 460132
Orange Book
A215389
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": "71335-2611_585d2da0-738a-48d3-8995-bdb8959a0193",
"productndc": "71335-2611",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215389",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Nov 28, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Nov 28, 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": "ANDA215389",
"marketing_category": "ANDA",
"nonproprietary_name": "Darunavir",
"start_marketing_date": "20231128",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code J05AE10.
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