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United States · US · US:0006-3603_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 · 2
- ndc11000636036060 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)
- ndc11000636036160 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)
Annotations
UNII (FDA Substance ID)
43Y000U234
RALTEGRAVIR POTASSIUM
RxCUI 1235585
Orange Book
N205786
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": "0006-3603_70b9b593-db43-43ad-8808-a1c86c048145",
"productndc": "0006-3603",
"dosage_form": "GRANULE, FOR SUSPENSION",
"orange_book": {
"appl_no": "205786",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE/PACKET",
"product_no": "001",
"approval_date": "Dec 20, 2013"
}
],
"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": "NDA205786",
"marketing_category": "NDA",
"nonproprietary_name": "RALTEGRAVIR",
"start_marketing_date": "20131220",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AJ01.
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