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United States · US · US:49702-226_a9175b83-2200-4bd2-9ee3-52095b5d2657

Tivicay

Orange BookUNIISPLATC J05AJ03

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

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AJ03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970222613
    30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)

Annotations

UNII (FDA Substance ID)
1Q1V9V5WYQ
DOLUTEGRAVIR SODIUM
RxCUI 1433867
Orange Book
N204790
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": {
    "485bc9db-8665-9f5a-e063-6394a90a7921": {
      "match": "brand_token",
      "title": "TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "49702-226_a9175b83-2200-4bd2-9ee3-52095b5d2657",
  "productndc": "49702-226",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204790",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Aug 12, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jun 9, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jun 9, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOLUTEGRAVIR SODIUM",
  "proprietary_name": "Tivicay",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204790",
  "marketing_category": "NDA",
  "nonproprietary_name": "dolutegravir sodium",
  "start_marketing_date": "20160609",
  "active_numerator_strength": "10"
}

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