67457-325 NDC - BENDAMUSTINE HYDROCHLORIDE ()

Drug Information

  • Product NDC: 67457-325
  • Proprietary Name: Bendamustine Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Mylan Institutional LLC
Product Type:
FDA Application Number: ANDA204104
Marketing Category: ANDA
Start Marketing Date:4/26/2018
End Marketing Date:2/21/2019

Package Information

No. Package Code Package Description Billing Unit
167457-325-125 mL in 1 VIAL, SINGLE-DOSE (67457-325-12)

NDC Record

Field Name Field Value Definition
PRODUCT NDC67457-325Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
PROPRIETARY NAMEBendamustine HydrochlorideName of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE4/26/2018An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
END MARKETING DATE2/21/2019 
MARKETING CATEGORY NAMEANDA 
APPLICATION NUMBERANDA204104This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMylan Institutional LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/19/2025

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