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United States · US · US:49702-255_a9175b83-2200-4bd2-9ee3-52095b5d2657

Tivicay PD

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
    4970225537
    1 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
1Q1V9V5WYQ
DOLUTEGRAVIR SODIUM
RxCUI 1433867
Orange Book
N213983
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": "49702-255_a9175b83-2200-4bd2-9ee3-52095b5d2657",
  "productndc": "49702-255",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "213983",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 12, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOLUTEGRAVIR SODIUM",
  "proprietary_name": "Tivicay PD",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213983",
  "marketing_category": "NDA",
  "nonproprietary_name": "dolutegravir sodium",
  "start_marketing_date": "20200612",
  "active_numerator_strength": "5"
}

Related drugs

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