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United States · US · US:0002-1717_1ece6e73-2242-434e-b297-7ccf07a54c1e

Inluriyo

Orange BookUNIISPL

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0002171728
    28 TABLET, FILM COATED in 1 BOTTLE (0002-1717-28)
  • ndc11
    0002171756
    56 TABLET, FILM COATED in 1 BOTTLE (0002-1717-56)
  • ndc11
    0002171761
    56 TABLET, FILM COATED in 1 BOTTLE (0002-1717-61)

Annotations

UNII (FDA Substance ID)
9CXQ3PF69U
IMLUNESTRANT
Orange Book
N218881
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9CXQ3PF69U",
    "rxcui": null,
    "inchikey": "UVBQMXOKKDCBJN-MUUNZHRXSA-N",
    "display_name": "IMLUNESTRANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5bc172e4-e8a2-441a-be52-279a7f890196": {
      "match": "brand_token",
      "title": "INLURIYO (IMLUNESTRANT) TABLET, FILM COATED [ELI LILLY AND COMPANY]",
      "spl_version": "6",
      "published_date": "2026-02-25"
    }
  },
  "productid": "0002-1717_1ece6e73-2242-434e-b297-7ccf07a54c1e",
  "productndc": "0002-1717",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218881",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Sep 25, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IMLUNESTRANT",
  "proprietary_name": "Inluriyo",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218881",
  "marketing_category": "NDA",
  "nonproprietary_name": "imlunestrant",
  "start_marketing_date": "20250925",
  "active_numerator_strength": "200"
}

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