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United States · US · US:42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434e
BELRAPZO
Orange BookUNIISPLATC L01AA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEagle Pharmaceuticals, Inc
CountryUS (United States)
ATC codeL01AA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142367521251 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
981Y8SX18M
BENDAMUSTINE HYDROCHLORIDE
RxCUI 1114693
Orange Book
N205580
AP
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": {
"9759a4ae-82ca-40cf-9c02-e1cadb21cbdc": {
"match": "brand_token",
"title": "BELRAPZO (BENDAMUSTINE HYDROCHLORIDE) INJECTION [EAGLE PHARMACEUTICALS, INC]",
"spl_version": "11",
"published_date": "2024-10-03"
}
},
"productid": "42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434e",
"productndc": "42367-521",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "205580",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100MG/4ML (25MG/ML)",
"product_no": "001",
"approval_date": "May 15, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENDAMUSTINE HYDROCHLORIDE",
"proprietary_name": "BELRAPZO",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA205580",
"marketing_category": "NDA",
"nonproprietary_name": "bendamustine hydrochloride",
"start_marketing_date": "20190603",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01AA09.
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