bendamustine hydrochloride

Generic: bendamustine hydrochloride

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendamustine hydrochloride
Generic Name bendamustine hydrochloride
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 100 mg/20mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-572
Product ID 68001-572_14ca6252-d081-3bdf-e063-6394a90abb8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205574
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001572
Hyphenated Format 68001-572

Supplemental Identifiers

RxCUI
1805001 1805007
UPC
0368001572415 0368007511418
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 ANDA205574 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-572-41) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68001-572-41 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-572-41) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bendamustine hydrochloride (100 mg/20mL)

Linked Drug Pages (1)

bendamustine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "14ca6252-d081-3bdf-e063-6394a90abb8d", "openfda": {"upc": ["0368001572415", "0368007511418"], "unii": ["981Y8SX18M"], "rxcui": ["1805001", "1805007"], "spl_set_id": ["0df025d2-c093-427a-b599-f605e71fe835"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-572-41)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-572-41", "marketing_start_date": "20231015"}], "brand_name": "bendamustine hydrochloride", "product_id": "68001-572_14ca6252-d081-3bdf-e063-6394a90abb8d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "68001-572", "generic_name": "bendamustine hydrochloride", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bendamustine hydrochloride", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "100 mg/20mL"}], "application_number": "ANDA205574", "marketing_category": "ANDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}