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United States · US · US:0002-2980_94e137ac-9f6b-4904-8999-3e55603a2407

RETEVMO

Orange BookUNIISPLATC L01EX22

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeL01EX22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0002298026
    120 CAPSULE in 1 BOTTLE (0002-2980-26)
  • ndc11
    0002298060
    60 CAPSULE in 1 BOTTLE (0002-2980-60)

Annotations

UNII (FDA Substance ID)
CEGM9YBNGD
SELPERCATINIB
RxCUI 2370147
Orange Book
N213246
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CEGM9YBNGD",
    "rxcui": "2370147",
    "inchikey": "XIIOFHFUYBLOLW-ZRZAMGCNSA-N",
    "display_name": "SELPERCATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7fa848ba-a59c-4144-9f52-64d090f4d828": {
      "match": "brand_token",
      "title": "RETEVMO (SELPERCATINIB) CAPSULE RETEVMO (SELPERCATINIB) TABLET, COATED [ELI LILLY AND COMPANY]",
      "spl_version": "22",
      "published_date": "2025-12-02"
    }
  },
  "productid": "0002-2980_94e137ac-9f6b-4904-8999-3e55603a2407",
  "productndc": "0002-2980",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213246",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELPERCATINIB",
  "proprietary_name": "RETEVMO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213246",
  "marketing_category": "NDA",
  "nonproprietary_name": "selpercatinib",
  "start_marketing_date": "20200508",
  "active_numerator_strength": "80"
}

Related drugs

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