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United States · US · US:59572-720_4707dba8-73ee-4119-805b-65c3f3a55b72
Inrebic
Orange BookUNIISPLATC L01EJ02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCelgene Corporation
CountryUS (United States)
ATC codeL01EJ02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115957272012120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)
Annotations
UNII (FDA Substance ID)
UH9J2HBQWJ
FEDRATINIB HYDROCHLORIDE
RxCUI 2197594
Orange Book
N212327
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UH9J2HBQWJ",
"rxcui": "2197594",
"inchikey": "QAFZLTVOFJHYDF-UHFFFAOYSA-N",
"display_name": "FEDRATINIB HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f0f55a2a-4e0c-4cba-8571-03e1424486d7": {
"match": "brand_token",
"title": "INREBIC (FEDRATINIB HYDROCHLORIDE) CAPSULE [CELGENE CORPORATION]",
"spl_version": "11",
"published_date": "2026-03-30"
}
},
"productid": "59572-720_4707dba8-73ee-4119-805b-65c3f3a55b72",
"productndc": "59572-720",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212327",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Aug 16, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FEDRATINIB HYDROCHLORIDE",
"proprietary_name": "Inrebic",
"active_ingred_unit": "mg/1",
"application_number": "NDA212327",
"marketing_category": "NDA",
"nonproprietary_name": "Fedratinib Hydrochloride",
"start_marketing_date": "20190816",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EJ02.
- ISInrebicBristol-Myers Squibb Pharma EEIG*
- PLInrebicBristol-Myers Squibb Pharma EEIG
- DKInrebicBristol-Myers Squibb Pharma EEIG
- NOInrebicBristol-Myers Squibb Pharma EEIG
- FIInrebicBristol-Myers Squibb Pharma EEIG
- CAINREBICBRISTOL-MYERS SQUIBB CANADA
- CZINREBICBristol-Myers Squibb Pharma EEIG, Dublin
- BEInrebic 100 mgBristol-Myers Squibb Pharma
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