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United States · US · US:61958-1701_ca3e7112-6dfe-403f-af6f-a0051e77d125
Zydelig
In shortageOrange BookUNIISPLATC L01EM01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeL01EM01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619581701160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)
Annotations
UNII (FDA Substance ID)
YG57I8T5M0
IDELALISIB
RxCUI 1544460
Orange Book
N205858
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Idelalisib Tablet
Raw payload (JSON)
{
"unii": {
"unii": "YG57I8T5M0",
"rxcui": "1544460",
"inchikey": "IFSDAJWBUCMOAH-HNNXBMFYSA-N",
"display_name": "IDELALISIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"efbdafa9-d18c-4e85-b4a2-1e620fc74e50": {
"match": "brand_token",
"title": "ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
"spl_version": "12",
"published_date": "2025-02-24"
}
},
"productid": "61958-1701_ca3e7112-6dfe-403f-af6f-a0051e77d125",
"productndc": "61958-1701",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205858",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 23, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Jul 23, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IDELALISIB",
"shortage_reason": "Idelalisib Tablet",
"shortage_status": "current",
"proprietary_name": "Zydelig",
"active_ingred_unit": "mg/1",
"application_number": "NDA205858",
"marketing_category": "NDA",
"nonproprietary_name": "idelalisib",
"start_marketing_date": "20140723",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EM01.
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