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United States · US · US:31722-089_30b10990-92c4-531b-e063-6294a90a7a27
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
- ndc11317220893030 TABLET, FILM COATED in 1 BOTTLE (31722-089-30)
Annotations
UNII (FDA Substance ID)
YO603Y8113
DARUNAVIR
RxCUI 460132
Orange Book
A216168
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": "31722-089_30b10990-92c4-531b-e063-6294a90a7a27",
"productndc": "31722-089",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216168",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Jan 21, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Jan 21, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DARUNAVIR",
"proprietary_name": "Darunavir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216168",
"marketing_category": "ANDA",
"nonproprietary_name": "Darunavir",
"start_marketing_date": "20250121",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code J05AE10.
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