🇺🇸
United States · US · US:0006-5092_36245cd8-5e98-408c-a2df-38f9642b0827
IDVYNSO
Orange BookUNIISPLATC J05AG
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ05AG
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11000650920130 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01)
- ndc11000650925914 TABLET, FILM COATED in 1 BOTTLE (0006-5092-59)
Annotations
UNII (FDA Substance ID)
913P6LK81M
DORAVIRINE
RxCUI 2055755
Orange Book
N216964
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "913P6LK81M",
"rxcui": "2055755",
"inchikey": "ZIAOVIPSKUPPQW-UHFFFAOYSA-N",
"display_name": "DORAVIRINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"11aaeb53-9848-433c-be7f-db8a5bc0b26f": {
"match": "brand_token",
"title": "IDVYNSO (DORAVIRINE, ISLATRAVIR) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
"spl_version": "2",
"published_date": "2026-05-04"
}
},
"productid": "0006-5092_36245cd8-5e98-408c-a2df-38f9642b0827",
"productndc": "0006-5092",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216964",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG;0.25MG",
"product_no": "001",
"approval_date": "Apr 20, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DORAVIRINE; ISLATRAVIR ANHYDROUS",
"proprietary_name": "IDVYNSO",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA216964",
"marketing_category": "NDA",
"nonproprietary_name": "Doravirine, Islatravir",
"start_marketing_date": "20260423",
"active_numerator_strength": "100; .25"
}Related drugs
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