NDC 63459-391

TREANDA

Bendamustine Hydrochloride

TREANDA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Bendamustine Hydrochloride.

• Product ID: 63459-391_3711a43c-3f0e-4954-b22f-38b45770f2b3
• NDC: 63459-391
• Product Type: Human Prescription Drug
• Proprietary Name: TREANDA
• Generic Name: Bendamustine Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA022249
• Labeler Name: Cephalon, Inc.
• Substance Name: BENDAMUSTINE HYDROCHLORIDE
• Active Ingredient Strength: 100 mg/20mL
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63459-391-20

1 VIAL, SINGLE-DOSE in 1 CARTON (63459-391-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2008-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-391-20 [63459039120]

TREANDA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022249
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-03-31

Drug Details

Active Ingredients

Ingredient	Strength
BENDAMUSTINE HYDROCHLORIDE	100 mg/20mL

OpenFDA Data

• SPL SET ID: 39d53698-57fa-7c99-fc5b-f52a55684826
• Manufacturer:
  • Cephalon, Inc.
• UNII:
  • 981Y8SX18M
• RxNorm Concept Unique ID - RxCUI:
  • 1805012
  • 1805004
  • 1805007
  • 1805011
  • 1805001
  • 1805015
  • 1805016
  • 1805009

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "TREANDA" or generic name "Bendamustine Hydrochloride"

NDC	Brand Name	Generic Name
63459-390	TREANDA	Bendamustine Hydrochloride
63459-391	TREANDA	Bendamustine Hydrochloride
42367-521	BELRAPZO	bendamustine hydrochloride
10019-079	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride
16729-250	bendamustine hydrochloride	bendamustine hydrochloride
16729-251	bendamustine hydrochloride	bendamustine hydrochloride
42367-520	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride
63459-348	Bendeka	bendamustine hydrochloride
71225-120	VIVIMUSTA	BENDAMUSTINE HYDROCHLORIDE