🇺🇸
United States · US · US:63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39de
Bendeka
Orange BookUNIISPLATC L01AA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeL01AA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163459348041 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
981Y8SX18M
BENDAMUSTINE HYDROCHLORIDE
RxCUI 1114693
Orange Book
N208194
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": {
"ace9a43b-f9bd-4896-abfe-0ef4fec67ddf": {
"match": "brand_token",
"title": "BENDEKA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "22",
"published_date": "2024-01-24"
}
},
"productid": "63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39de",
"productndc": "63459-348",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "208194",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/4ML (25MG/ML)",
"product_no": "001",
"approval_date": "Dec 7, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENDAMUSTINE HYDROCHLORIDE",
"proprietary_name": "Bendeka",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208194",
"marketing_category": "NDA",
"nonproprietary_name": "bendamustine hydrochloride",
"start_marketing_date": "20151208",
"active_numerator_strength": "25"
}Related drugs
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