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United States · US · US:60687-819_1a392399-f30c-b533-e063-6294a90a1e67
Darunavir
Orange BookUNIISPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11606878192130 BLISTER PACK in 1 CARTON (60687-819-21) / 1 TABLET in 1 BLISTER PACK (60687-819-11)
Annotations
UNII (FDA Substance ID)
KPC4NRB25L
DARUNAVIR DIHYDRATE
Orange Book
A206288
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "KPC4NRB25L",
"rxcui": null,
"inchikey": "QBRFTVBGMDIHGZ-OCMLJPQKSA-N",
"display_name": "DARUNAVIR DIHYDRATE",
"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": "60687-819_1a392399-f30c-b533-e063-6294a90a1e67",
"productndc": "60687-819",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206288",
"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 DIHYDRATE",
"proprietary_name": "Darunavir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206288",
"marketing_category": "ANDA",
"nonproprietary_name": "Darunavir",
"start_marketing_date": "20240609",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code J05AE10.
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