🇺🇸
United States · US · US:69097-248_e3d4803e-30b2-4c8b-90e3-b04c2da4b1c9
Darunavir 600 and 800 mg
Orange BookSPLATC J05AE10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeJ05AE10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11690972480360 TABLET in 1 BOTTLE (69097-248-03)
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": "69097-248_e3d4803e-30b2-4c8b-90e3-b04c2da4b1c9",
"productndc": "69097-248",
"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 600 and 800 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206288",
"marketing_category": "ANDA",
"nonproprietary_name": "darunavir",
"start_marketing_date": "20231129",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J05AE10.
Access this data programmatically
Query Darunavir 600 and 800 mg and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.