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United States · US · US:0006-5007_237e7245-b6e8-40df-8d66-4bb122136834

DELSTRIGO

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 · 1

  • ndc11
    0006500701
    30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)

Annotations

UNII (FDA Substance ID)
913P6LK81M
DORAVIRINE
RxCUI 2055755
Orange Book
N210807
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": {
    "cd1e9f84-607a-46d3-b01e-2736018d67b6": {
      "match": "brand_token",
      "title": "DELSTRIGO (DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
      "spl_version": "23",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0006-5007_237e7245-b6e8-40df-8d66-4bb122136834",
  "productndc": "0006-5007",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210807",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG;300MG;300MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "DELSTRIGO",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA210807",
  "marketing_category": "NDA",
  "nonproprietary_name": "doravirine, lamivudine, and tenofovir disoproxil fumarate",
  "start_marketing_date": "20180720",
  "active_numerator_strength": "100; 300; 300"
}

Related drugs

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