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United States · US · US:71860-101_34f9bf77-6d88-5782-e063-6294a90a6c54

TRYNGOLZA

Orange BookUNIISPL

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

Identification

ManufacturerIonis Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7186010101
    1 SYRINGE, GLASS in 1 CARTON (71860-101-01) / .8 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
NSY2BY6PSB
OLEZARSEN SODIUM
Orange Book
N218614
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NSY2BY6PSB",
    "rxcui": null,
    "inchikey": null,
    "display_name": "OLEZARSEN SODIUM",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "0f51aa8e-8475-8cf9-e063-6394a90a6848": {
      "match": "brand_token",
      "title": "TRYNGOLZA (OLEZARSEN SODIUM) INJECTION, SOLUTION [IONIS PHARMACEUTICALS, INC.]",
      "spl_version": "6",
      "published_date": "2025-05-14"
    }
  },
  "productid": "71860-101_34f9bf77-6d88-5782-e063-6294a90a6c54",
  "productndc": "71860-101",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218614",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)",
        "product_no": "001",
        "approval_date": "Dec 19, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLEZARSEN SODIUM",
  "proprietary_name": "TRYNGOLZA",
  "active_ingred_unit": "mg/.8mL",
  "application_number": "NDA218614",
  "marketing_category": "NDA",
  "nonproprietary_name": "olezarsen sodium",
  "start_marketing_date": "20241219",
  "active_numerator_strength": "80"
}

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