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United States · US · US:75007-501_1393b9d2-c8d3-49f9-8665-5cc3a083f0c7
Bortezomib
Orange BookUNIISPLATC L01XG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNingbo Shuangcheng Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeL01XG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11750075013110 VIAL in 1 CARTON (75007-501-31) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
- ndc1175007501321 VIAL in 1 CARTON (75007-501-32) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
A216528
AP
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": {
"decb5d94-2ea2-48d8-b08b-3196b24c0ed3": {
"match": "brand_token",
"title": "BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY, LLC]",
"spl_version": "1",
"published_date": "2026-05-01"
}
},
"productid": "75007-501_1393b9d2-c8d3-49f9-8665-5cc3a083f0c7",
"productndc": "75007-501",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "216528",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "3.5MG/VIAL",
"product_no": "001",
"approval_date": "Dec 17, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BORTEZOMIB",
"proprietary_name": "Bortezomib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216528",
"marketing_category": "ANDA",
"nonproprietary_name": "Bortezomib",
"start_marketing_date": "20251217",
"active_numerator_strength": "3.5"
}Related drugs
Other records sharing ATC code L01XG01.
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