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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

  • ndc11
    0006509201
    30 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01)
  • ndc11
    0006509259
    14 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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