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United States · US · US:31722-567_06f285d0-a267-615d-e063-6394a90a68ff
Darunavir
Orange BookUNIISPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11317225676060 TABLET, FILM COATED in 1 BOTTLE (31722-567-60)
Annotations
UNII (FDA Substance ID)
YO603Y8113
DARUNAVIR
RxCUI 460132
Orange Book
A202083
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": "31722-567_06f285d0-a267-615d-e063-6394a90a68ff",
"productndc": "31722-567",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202083",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Sep 14, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Sep 14, 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": "ANDA202083",
"marketing_category": "ANDA",
"nonproprietary_name": "Darunavir",
"start_marketing_date": "20230914",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AE10.
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