🇺🇸
United States · US · US:68071-2113_1d749c51-f082-f9d5-e063-6394a90a4d8f
ISENTRESS
Orange BookUNIISPLATC J05AJ01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ05AJ01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168071211366 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6)
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": "68071-2113_1d749c51-f082-f9d5-e063-6394a90a4d8f",
"productndc": "68071-2113",
"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.