🇺🇸
United States · US · US:83831-183_6c0bc00a-dd5f-4305-85d6-bd534e947e32
BENDAMUSTINE HYDROCHLORIDE
Orange BookUNIISPLATC L01AA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvyxa Pharma, LLC
CountryUS (United States)
ATC codeL01AA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183831183041 VIAL in 1 CARTON (83831-183-04) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
981Y8SX18M
BENDAMUSTINE HYDROCHLORIDE
RxCUI 1114693
Orange Book
N219014
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "981Y8SX18M",
"rxcui": "1114693",
"inchikey": "ZHSKUOZOLHMKEA-UHFFFAOYSA-N",
"display_name": "BENDAMUSTINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f359e7c6-d104-457d-a7fe-597c74440353": {
"match": "brand_token",
"title": "BENDAMUSTINE HYDROCHLORIDE INJECTION [AVYXA PHARMA, LLC]",
"spl_version": "1",
"published_date": "2026-05-29"
}
},
"productid": "83831-183_6c0bc00a-dd5f-4305-85d6-bd534e947e32",
"productndc": "83831-183",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "219014",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/4ML (25MG/ML)",
"product_no": "001",
"approval_date": "Jul 3, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENDAMUSTINE HYDROCHLORIDE",
"proprietary_name": "BENDAMUSTINE HYDROCHLORIDE",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA219014",
"marketing_category": "NDA",
"nonproprietary_name": "bendamustine hydrochloride",
"start_marketing_date": "20260529",
"active_numerator_strength": "100"
}Related drugs
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