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United States · US · US:70121-2484_6fb2ce70-c98f-4e46-9b0f-6aec0530f61d
BORUZU
Orange BookUNIISPLATC L01XG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01XG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121248411 VIAL, SINGLE-DOSE in 1 CARTON (70121-2484-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
N212782
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "69G8BD63PP",
"rxcui": "358258",
"inchikey": "GXJABQQUPOEUTA-RDJZCZTQSA-N",
"display_name": "BORTEZOMIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS; SUBCUTANEOUS",
"spl_meta": {
"b92628dd-fa09-4c3a-b6a3-66426025807c": {
"match": "brand_token",
"title": "BORUZU (BORTEZOMIB) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "2",
"published_date": "2025-08-08"
}
},
"productid": "70121-2484_6fb2ce70-c98f-4e46-9b0f-6aec0530f61d",
"productndc": "70121-2484",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "212782",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3.5MG/1.4ML (2.5MG/ML)",
"product_no": "001",
"approval_date": "Aug 26, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BORTEZOMIB",
"proprietary_name": "BORUZU",
"active_ingred_unit": "mg/1.4mL",
"application_number": "NDA212782",
"marketing_category": "NDA",
"nonproprietary_name": "Bortezomib",
"start_marketing_date": "20240927",
"active_numerator_strength": "3.5"
}Related drugs
Other records sharing ATC code L01XG01.
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