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United States · US · US:69794-050_a89d49c1-092a-4911-bbcc-611479f4c444

DOJOLVI

Orange BookUNIISPLATC A16AX17

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

Identification

ManufacturerUltragenyx Pharmaceutical Inc.
CountryUS (United States)
ATC codeA16AX17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6979405050
    1 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
2P6O7CFW5K
TRIHEPTANOIN
RxCUI 1313234
Orange Book
N213687
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2P6O7CFW5K",
    "rxcui": "1313234",
    "inchikey": "PJHKBYALYHRYSK-UHFFFAOYSA-N",
    "display_name": "TRIHEPTANOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4cfeb8bd-143e-4dd7-bc34-b0bcda02460d": {
      "match": "brand_token",
      "title": "DOJOLVI (TRIHEPTANOIN) LIQUID [ULTRAGENYX PHARMACEUTICAL INC.]",
      "spl_version": "17",
      "published_date": "2025-11-26"
    }
  },
  "productid": "69794-050_a89d49c1-092a-4911-bbcc-611479f4c444",
  "productndc": "69794-050",
  "dosage_form": "LIQUID",
  "orange_book": {
    "appl_no": "213687",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100% w/w",
        "product_no": "001",
        "approval_date": "Jun 30, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIHEPTANOIN",
  "proprietary_name": "DOJOLVI",
  "active_ingred_unit": "g/mL",
  "application_number": "NDA213687",
  "marketing_category": "NDA",
  "nonproprietary_name": "Triheptanoin",
  "start_marketing_date": "20200701",
  "active_numerator_strength": ".96"
}

Related drugs

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