bendeka

Generic: bendamustine hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendeka
Generic Name bendamustine hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 25 mg/mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 63459-348
Product ID 63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208194
Listing Expiration 2026-12-31
Marketing Start 2015-12-08

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63459348
Hyphenated Format 63459-348

Supplemental Identifiers

RxCUI
1726097 1726102
UPC
0363459348049
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 bendeka (source: ndc)
Generic Name bendamustine hydrochloride (source: ndc)
Application Number NDA208194 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

63459-348-04 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

bendamustine hydrochloride (25 mg/mL)

Linked Drug Pages (1)

Bendeka ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "bcfd315e-9ade-4659-9f1c-dfb687ba39de", "openfda": {"upc": ["0363459348049"], "unii": ["981Y8SX18M"], "rxcui": ["1726097", "1726102"], "spl_set_id": ["ace9a43b-f9bd-4896-abfe-0ef4fec67ddf"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04)  / 4 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63459-348-04", "marketing_start_date": "20151208"}], "brand_name": "Bendeka", "product_id": "63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39de", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "63459-348", "generic_name": "bendamustine hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bendeka", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "NDA208194", "marketing_category": "NDA", "marketing_start_date": "20151208", "listing_expiration_date": "20261231"}