bendamustine hydrochloride

Generic: bendamustine hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendamustine hydrochloride
Generic Name bendamustine hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 100 mg/1

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 10019-079
Product ID 10019-079_3d05da71-982b-4d45-8d2f-4eee390f5172
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216078
Listing Expiration 2026-12-31
Marketing Start 2022-12-15

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10019079
Hyphenated Format 10019-079

Supplemental Identifiers

RxCUI
1726097
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 NDA216078 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (10019-079-01) / 1 INJECTION in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

10019-079-01 1 VIAL, MULTI-DOSE in 1 CARTON (10019-079-01) / 1 INJECTION in 1 VIAL, MULTI-DOSE

Ingredients (1)

bendamustine hydrochloride (100 mg/1)

Linked Drug Pages (1)

BENDAMUSTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3d05da71-982b-4d45-8d2f-4eee390f5172", "openfda": {"unii": ["981Y8SX18M"], "rxcui": ["1726097"], "spl_set_id": ["766b73e2-49bb-47f9-bbb1-44cfa1a3197e"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (10019-079-01)  / 1 INJECTION in 1 VIAL, MULTI-DOSE", "package_ndc": "10019-079-01", "marketing_start_date": "20221215"}], "brand_name": "BENDAMUSTINE HYDROCHLORIDE", "product_id": "10019-079_3d05da71-982b-4d45-8d2f-4eee390f5172", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "10019-079", "generic_name": "bendamustine hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENDAMUSTINE HYDROCHLORIDE", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "NDA216078", "marketing_category": "NDA", "marketing_start_date": "20221215", "listing_expiration_date": "20261231"}