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United States · US · US:0409-1704_e7c31651-e301-43f9-bc81-e0fd5dcb828c
BORTEZOMIB
Orange BookUNIISPLATC L01XG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeL01XG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104091704011 VIAL, SINGLE-DOSE in 1 CARTON (0409-1704-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
N209191
APAP
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": "0409-1704_e7c31651-e301-43f9-bc81-e0fd5dcb828c",
"productndc": "0409-1704",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "209191",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1MG/VIAL",
"product_no": "001",
"approval_date": "May 2, 2022"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "2.5MG/VIAL",
"product_no": "002",
"approval_date": "May 2, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BORTEZOMIB",
"proprietary_name": "BORTEZOMIB",
"active_ingred_unit": "mg/1",
"application_number": "NDA209191",
"marketing_category": "NDA",
"nonproprietary_name": "BORTEZOMIB",
"start_marketing_date": "20220516",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01XG01.
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