belrapzo

Generic: bendamustine hydrochloride

Labeler: eagle pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name belrapzo
Generic Name bendamustine hydrochloride
Labeler eagle pharmaceuticals, inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 100 mg/4mL

Manufacturer
Eagle Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 42367-521
Product ID 42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205580
Listing Expiration 2026-12-31
Marketing Start 2019-06-03

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42367521
Hyphenated Format 42367-521

Supplemental Identifiers

RxCUI
1726097 2178266
UPC
0342367521256
UNII
981Y8SX18M

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name belrapzo (source: ndc)
Generic Name bendamustine hydrochloride (source: ndc)
Application Number NDA205580 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/4mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

42367-521-25 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

bendamustine hydrochloride (100 mg/4mL)

Linked Drug Pages (1)

BELRAPZO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7e2a2a05-9122-41c0-acf0-a1231a57434e", "openfda": {"upc": ["0342367521256"], "unii": ["981Y8SX18M"], "rxcui": ["1726097", "2178266"], "spl_set_id": ["9759a4ae-82ca-40cf-9c02-e1cadb21cbdc"], "manufacturer_name": ["Eagle Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25)  / 4 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "42367-521-25", "marketing_start_date": "20190603"}], "brand_name": "BELRAPZO", "product_id": "42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434e", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "42367-521", "generic_name": "bendamustine hydrochloride", "labeler_name": "Eagle Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BELRAPZO", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "100 mg/4mL"}], "application_number": "NDA205580", "marketing_category": "NDA", "marketing_start_date": "20190603", "listing_expiration_date": "20261231"}