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United States · US · US:49702-231_4018a8c7-db0d-481e-b50a-a469ba32ec4b

Triumeq

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970223113
    30 TABLET, FILM COATED in 1 BOTTLE (49702-231-13)

Annotations

UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
N205551
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J220T4J9Q2",
    "rxcui": "221052",
    "inchikey": "WMHSRBZIJNQHKT-FFKFEZPRSA-N",
    "display_name": "ABACAVIR SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2997739a-aa91-42aa-a206-a70e2db7b84f": {
      "match": "brand_token",
      "title": "TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED TRIUMEQ PD (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) KIT [VIIV HEALTHCARE COMPANY]",
      "spl_version": "30",
      "published_date": "2026-01-26"
    }
  },
  "productid": "49702-231_4018a8c7-db0d-481e-b50a-a469ba32ec4b",
  "productndc": "49702-231",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205551",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 600MG BASE;EQ 50MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Aug 22, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE",
  "proprietary_name": "Triumeq",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA205551",
  "marketing_category": "NDA",
  "nonproprietary_name": "abacavir sulfate, dolutegravir sodium, lamivudine",
  "start_marketing_date": "20140822",
  "active_numerator_strength": "600; 50; 300"
}

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