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United States · US · US:59676-565_3d80bc62-24ac-c092-e063-6394a90a7bba
PREZISTA
Orange BookUNIISPLATC J05AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Products LP
CountryUS (United States)
ATC codeJ05AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159676565011 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
33O78XF0BW
DARUNAVIR ETHANOLATE
RxCUI 644682
Orange Book
N202895
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "33O78XF0BW",
"rxcui": "644682",
"inchikey": "QWSHKNICRJHQCY-VBTXLZOXSA-N",
"display_name": "DARUNAVIR ETHANOLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"814301f9-c990-46a5-b481-2879a521a16f": {
"match": "brand_token",
"title": "PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]",
"spl_version": "58",
"published_date": "2025-09-01"
}
},
"productid": "59676-565_3d80bc62-24ac-c092-e063-6394a90a7bba",
"productndc": "59676-565",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "202895",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Dec 16, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DARUNAVIR ETHANOLATE",
"proprietary_name": "PREZISTA",
"active_ingred_unit": "mg/mL",
"application_number": "NDA202895",
"marketing_category": "NDA",
"nonproprietary_name": "darunavir",
"start_marketing_date": "20111216",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AE.
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- 🇺🇸DarunavirAurobindo Pharma Limited
- 🇺🇸DARUNAVIRLupin Pharmaceuticals, Inc.
- 🇺🇸DARUNAVIRLupin Pharmaceuticals, Inc.
- 🇺🇸EVOTAZE.R. Squibb & Sons, L.L.C.
- GBEvotaz 300mg/150mg tabletsBristol-Myers Squibb Pharmaceuticals Ltd
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