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United States · US · US:76282-738_d4f6fed4-1a95-4d9a-8395-13818dedccd3
darunavir
Orange BookSPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEXELAN PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11762827383030 TABLET in 1 BOTTLE (76282-738-30)
Annotations
Orange Book
A206288
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "76282-738_d4f6fed4-1a95-4d9a-8395-13818dedccd3",
"productndc": "76282-738",
"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 HYDRATE",
"proprietary_name": "darunavir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206288",
"marketing_category": "ANDA",
"nonproprietary_name": "darunavir 800 mg",
"start_marketing_date": "20240119",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code J05AE10.
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