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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
- ndc11000269023030 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.
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