🇺🇸
United States · US · US:0006-0227_70b9b593-db43-43ad-8808-a1c86c048145
ISENTRESS
Orange BookUNIISPLATC J05AJ01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ05AJ01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11000602276160 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61)
Annotations
UNII (FDA Substance ID)
43Y000U234
RALTEGRAVIR POTASSIUM
RxCUI 1235585
Orange Book
N022145
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "43Y000U234",
"rxcui": "1235585",
"inchikey": "IFUKBHBISRAZTF-UHFFFAOYSA-M",
"display_name": "RALTEGRAVIR POTASSIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"89a5ec53-d956-4329-8004-0f40f51c88a3": {
"match": "brand_token",
"title": "ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]",
"spl_version": "70",
"published_date": "2025-11-17"
}
},
"productid": "0006-0227_70b9b593-db43-43ad-8808-a1c86c048145",
"productndc": "0006-0227",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022145",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 400MG BASE",
"product_no": "001",
"approval_date": "Oct 12, 2007"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 600MG BASE",
"product_no": "002",
"approval_date": "May 26, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RALTEGRAVIR POTASSIUM",
"proprietary_name": "ISENTRESS",
"active_ingred_unit": "mg/1",
"application_number": "NDA022145",
"marketing_category": "NDA",
"nonproprietary_name": "RALTEGRAVIR",
"start_marketing_date": "20071012",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AJ01.
Access this data programmatically
Query ISENTRESS 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.