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United States · US · US:70771-1745_1b288e91-dedb-465d-8c45-eb464dc72e89
Darunavir
Orange BookUNIISPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117077117455500 TABLET, FILM COATED in 1 BOTTLE (70771-1745-5)
- ndc11707711745660 TABLET, FILM COATED in 1 BOTTLE (70771-1745-6)
- ndc117077117458180 TABLET, FILM COATED in 1 BOTTLE (70771-1745-8)
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": "70771-1745_1b288e91-dedb-465d-8c45-eb464dc72e89",
"productndc": "70771-1745",
"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": "600"
}Related drugs
Other records sharing ATC code J05AE10.
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