bendamustine hydrochloride

Generic: bendamustine hydrochloride

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendamustine hydrochloride
Generic Name bendamustine hydrochloride
Labeler apotex corp
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 25 mg/mL

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-6228
Product ID 60505-6228_5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215033
Listing Expiration 2026-12-31
Marketing Start 2023-04-26

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056228
Hyphenated Format 60505-6228

Supplemental Identifiers

RxCUI
1726097
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 NDA215033 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

60505-6228-0 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

bendamustine hydrochloride (25 mg/mL)

Linked Drug Pages (1)

Bendamustine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a", "openfda": {"unii": ["981Y8SX18M"], "rxcui": ["1726097"], "spl_set_id": ["085dd54c-4212-d879-afef-ee52732a48c0"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "60505-6228-0", "marketing_start_date": "20230426"}], "brand_name": "Bendamustine Hydrochloride", "product_id": "60505-6228_5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "60505-6228", "generic_name": "Bendamustine Hydrochloride", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bendamustine Hydrochloride", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "NDA215033", "marketing_category": "NDA", "marketing_start_date": "20230426", "listing_expiration_date": "20261231"}