treanda

Generic: bendamustine hydrochloride

Labeler: cephalon, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

bendamustine hydrochloride 25 mg/5mL

Manufacturer
Cephalon, LLC

Identifiers & Regulatory

Product NDC 63459-390
Product ID 63459-390_77ae475d-2d59-4fe2-8de7-833b6fc9d51a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022249
Listing Expiration 2026-12-31
Marketing Start 2010-01-05

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63459390
Hyphenated Format 63459-390

Supplemental Identifiers

RxCUI
1805001 1805004 1805007 1805009 1805011 1805012 1805015 1805016
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 treanda (source: ndc)
Generic Name bendamustine hydrochloride (source: ndc)
Application Number NDA022249 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63459-390-08 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bendamustine hydrochloride (25 mg/5mL)

Linked Drug Pages (1)

TREANDA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "77ae475d-2d59-4fe2-8de7-833b6fc9d51a", "openfda": {"unii": ["981Y8SX18M"], "rxcui": ["1805001", "1805004", "1805007", "1805009", "1805011", "1805012", "1805015", "1805016"], "spl_set_id": ["39d53698-57fa-7c99-fc5b-f52a55684826"], "manufacturer_name": ["Cephalon, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63459-390-08", "marketing_start_date": "20100105"}], "brand_name": "TREANDA", "product_id": "63459-390_77ae475d-2d59-4fe2-8de7-833b6fc9d51a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "63459-390", "generic_name": "Bendamustine Hydrochloride", "labeler_name": "Cephalon, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TREANDA", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "25 mg/5mL"}], "application_number": "NDA022249", "marketing_category": "NDA", "marketing_start_date": "20100105", "listing_expiration_date": "20261231"}