Back to search
🇺🇸

United States · US · US:0002-6902_ef421dc8-11db-4e6c-9154-dc04782cb52c

JAYPIRCA

Orange BookUNIISPLATC L01EL05

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeL01EL05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0002690230
    30 TABLET, COATED in 1 BOTTLE (0002-6902-30)

Annotations

UNII (FDA Substance ID)
JNA39I7ZVB
PIRTOBRUTINIB
Orange Book
N216059
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JNA39I7ZVB",
    "rxcui": null,
    "inchikey": "FWZAWAUZXYCBKZ-NSHDSACASA-N",
    "display_name": "PIRTOBRUTINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bd551845-0878-49a4-860f-839b83f6b801": {
      "match": "brand_token",
      "title": "JAYPIRCA (PIRTOBRUTINIB) TABLET, COATED [ELI LILLY AND COMPANY]",
      "spl_version": "14",
      "published_date": "2026-03-25"
    }
  },
  "productid": "0002-6902_ef421dc8-11db-4e6c-9154-dc04782cb52c",
  "productndc": "0002-6902",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "216059",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIRTOBRUTINIB",
  "proprietary_name": "JAYPIRCA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216059",
  "marketing_category": "NDA",
  "nonproprietary_name": "pirtobrutinib",
  "start_marketing_date": "20230127",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code L01EL05.

Access this data programmatically

Query JAYPIRCA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.