bendamustine hydrochloride

Generic: bendamustine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendamustine hydrochloride
Generic Name bendamustine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 25 mg/5mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-391
Product ID 55150-391_4357b1f0-fcc2-448a-9580-13b55ba470de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214739
Listing Expiration 2026-12-31
Marketing Start 2023-06-05

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150391
Hyphenated Format 55150-391

Supplemental Identifiers

RxCUI
1805001 1805007
UPC
0355150391011
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 bendamustine hydrochloride (source: ndc)
Generic Name bendamustine hydrochloride (source: ndc)
Application Number ANDA214739 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-391-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-391-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-391-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bendamustine hydrochloride (25 mg/5mL)

Linked Drug Pages (1)

BENDAMUSTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4357b1f0-fcc2-448a-9580-13b55ba470de", "openfda": {"upc": ["0355150391011"], "unii": ["981Y8SX18M"], "rxcui": ["1805001", "1805007"], "spl_set_id": ["dbe34bc1-06b2-493f-8859-e8b143357aa8"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-391-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-391-01", "marketing_start_date": "20230605"}], "brand_name": "BENDAMUSTINE HYDROCHLORIDE", "product_id": "55150-391_4357b1f0-fcc2-448a-9580-13b55ba470de", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "55150-391", "generic_name": "BENDAMUSTINE HYDROCHLORIDE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENDAMUSTINE HYDROCHLORIDE", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "25 mg/5mL"}], "application_number": "ANDA214739", "marketing_category": "ANDA", "marketing_start_date": "20230605", "listing_expiration_date": "20261231"}