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United States · US · US:49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957

Dovato

Orange BookUNIISPLATC J05AJ

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AJ
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4970224613
    30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)
  • ndc11
    4970224633
    1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    4970224662
    1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
1Q1V9V5WYQ
DOLUTEGRAVIR SODIUM
RxCUI 1433867
Orange Book
N211994
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1Q1V9V5WYQ",
    "rxcui": "1433867",
    "inchikey": "UGWJRRXTMKRYNK-VSLILLSYSA-M",
    "display_name": "DOLUTEGRAVIR SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "68e45422-43ed-4cfb-9356-fae88d14a53a": {
      "match": "brand_token",
      "title": "DOVATO (DOLUTEGRAVIR SODIUM AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]",
      "spl_version": "19",
      "published_date": "2026-01-23"
    }
  },
  "productid": "49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957",
  "productndc": "49702-246",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211994",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Apr 8, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOLUTEGRAVIR SODIUM; LAMIVUDINE",
  "proprietary_name": "Dovato",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA211994",
  "marketing_category": "NDA",
  "nonproprietary_name": "dolutegravir sodium and lamivudine",
  "start_marketing_date": "20190408",
  "active_numerator_strength": "50; 300"
}

Related drugs

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