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United States · US · US:0002-4732_609e7391-6d27-4d0d-bd00-f9cdb75a3070

Olumiant

Orange BookUNIISPLATC L04AF02

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeL04AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0002473230
    30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)

Annotations

UNII (FDA Substance ID)
ISP4442I3Y
BARICITINIB
RxCUI 2047232
Orange Book
N207924
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ISP4442I3Y",
    "rxcui": "2047232",
    "inchikey": "XUZMWHLSFXCVMG-UHFFFAOYSA-N",
    "display_name": "BARICITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "866e9f35-9035-4581-a4b1-75a621ab55cf": {
      "match": "brand_token",
      "title": "OLUMIANT (BARICITINIB) TABLET, FILM COATED [ELI LILLY AND COMPANY]",
      "spl_version": "28",
      "published_date": "2026-04-24"
    }
  },
  "productid": "0002-4732_609e7391-6d27-4d0d-bd00-f9cdb75a3070",
  "productndc": "0002-4732",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207924",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "May 31, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 8, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "May 10, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BARICITINIB",
  "proprietary_name": "Olumiant",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207924",
  "marketing_category": "NDA",
  "nonproprietary_name": "baricitinib",
  "start_marketing_date": "20191008",
  "active_numerator_strength": "1"
}

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