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United States · US · US:0006-3069_20dc2455-4d48-4183-b1ad-29a2686dcd2a
PIFELTRO
Orange BookUNIISPLATC J05AG06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ05AG06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11000630690130 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)
Annotations
UNII (FDA Substance ID)
913P6LK81M
DORAVIRINE
RxCUI 2055755
Orange Book
N210806
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": {
"76ce1f00-28c0-4314-bd2c-d473fe3d0970": {
"match": "brand_token",
"title": "PIFELTRO (DORAVIRINE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
"spl_version": "20",
"published_date": "2025-11-18"
}
},
"productid": "0006-3069_20dc2455-4d48-4183-b1ad-29a2686dcd2a",
"productndc": "0006-3069",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210806",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 30, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DORAVIRINE",
"proprietary_name": "PIFELTRO",
"active_ingred_unit": "mg/1",
"application_number": "NDA210806",
"marketing_category": "NDA",
"nonproprietary_name": "doravirine",
"start_marketing_date": "20180720",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AG06.
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