ORSERDU

Orange BookUNIISPLATC L02BA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerStemline Therapeutics, Inc.

CountryUS (United States)

ATC codeL02BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218701023
30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3)

Annotations

UNII (FDA Substance ID)

FM6A2627A8

ELACESTRANT

Orange Book

N217639

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "FM6A2627A8",
    "rxcui": null,
    "inchikey": "SIFNOOUKXBRGGB-AREMUKBSSA-N",
    "display_name": "ELACESTRANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aa66ae5c-2bd2-4444-8178-b55651e054ef": {
      "match": "brand_token",
      "title": "ORSERDU (ELACESTRANT) TABLET, FILM COATED [STEMLINE THERAPEUTICS, INC.]",
      "spl_version": "5",
      "published_date": "2024-08-05"
    }
  },
  "productid": "72187-0102_42ec5c9c-8984-4561-a4eb-c6ddc916c18a",
  "productndc": "72187-0102",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217639",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 86MG BASE",
        "product_no": "001",
        "approval_date": "Jan 27, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 345MG BASE",
        "product_no": "002",
        "approval_date": "Jan 27, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELACESTRANT",
  "proprietary_name": "ORSERDU",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217639",
  "marketing_category": "NDA",
  "nonproprietary_name": "Elacestrant",
  "start_marketing_date": "20230127",
  "active_numerator_strength": "345"
}

Related drugs

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