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United States · US · US:63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733a
Bortezomib
Orange BookUNIISPLATC L01XG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerShilpa Medicare Limited
CountryUS (United States)
ATC codeL01XG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163759303211 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 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": {
"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": "63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733a",
"productndc": "63759-3032",
"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": "Bortezomib",
"active_ingred_unit": "mg/1.4mL",
"application_number": "NDA212782",
"marketing_category": "NDA",
"nonproprietary_name": "Bortezomib",
"start_marketing_date": "20240925",
"active_numerator_strength": "3.5"
}Related drugs
Other records sharing ATC code L01XG01.
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