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United States · US · US:83634-208_e6157e3e-7111-4e20-bdd8-2c7d74d5e7b4
Bortezomib
Orange BookUNIISPLATC L01XG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvenacy, LLC
CountryUS (United States)
ATC codeL01XG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183634208101 VIAL in 1 CARTON (83634-208-10) / 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": "83634-208_e6157e3e-7111-4e20-bdd8-2c7d74d5e7b4",
"productndc": "83634-208",
"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": "20260501",
"active_numerator_strength": "3.5"
}Related drugs
Other records sharing ATC code L01XG01.
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