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United States · US · US:73116-215_30ff13f0-1e77-43de-99c9-c309834f1e63
COPIKTRA
Orange BookUNIISPLATC L01EM04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSecura Bio, Inc
CountryUS (United States)
ATC codeL01EM04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11731162152828 CAPSULE in 1 PACKAGE (73116-215-28)
- ndc11731162155656 CAPSULE in 1 PACKAGE (73116-215-56)
Annotations
UNII (FDA Substance ID)
610V23S0JI
DUVELISIB
RxCUI 2058509
Orange Book
N211155
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "610V23S0JI",
"rxcui": "2058509",
"inchikey": "SJVQHLPISAIATJ-ZDUSSCGKSA-N",
"display_name": "DUVELISIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e3c5ac56-e1f6-473a-bc73-687836534780": {
"match": "brand_token",
"title": "COPIKTRA (DUVELISIB) CAPSULE [SECURA BIO, INC]",
"spl_version": "4",
"published_date": "2025-12-23"
}
},
"productid": "73116-215_30ff13f0-1e77-43de-99c9-c309834f1e63",
"productndc": "73116-215",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211155",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "15MG",
"product_no": "001",
"approval_date": "Sep 24, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "002",
"approval_date": "Sep 24, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DUVELISIB",
"proprietary_name": "COPIKTRA",
"active_ingred_unit": "mg/1",
"application_number": "NDA211155",
"marketing_category": "NDA",
"nonproprietary_name": "duvelisib",
"start_marketing_date": "20180925",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code L01EM04.
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