bendamustine

Generic: bendamustine hcl

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendamustine
Generic Name bendamustine hcl
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 100 mg/20mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-103
Product ID 71288-103_f9917f10-8be6-4e83-b4d2-cc1fda074337
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211001
Listing Expiration 2026-12-31
Marketing Start 2023-06-05

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288103
Hyphenated Format 71288-103

Supplemental Identifiers

RxCUI
1805001 1805007
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 (source: ndc)
Generic Name bendamustine hcl (source: ndc)
Application Number ANDA211001 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-103-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-103-20 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-103-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bendamustine hydrochloride (100 mg/20mL)

Linked Drug Pages (1)

Bendamustine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f9917f10-8be6-4e83-b4d2-cc1fda074337", "openfda": {"unii": ["981Y8SX18M"], "rxcui": ["1805001", "1805007"], "spl_set_id": ["40f6f58d-d9ac-4f65-9fc7-16984bf1f180"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-103-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-103-20", "marketing_start_date": "20230605"}], "brand_name": "Bendamustine", "product_id": "71288-103_f9917f10-8be6-4e83-b4d2-cc1fda074337", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "71288-103", "generic_name": "Bendamustine HCl", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bendamustine", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "100 mg/20mL"}], "application_number": "ANDA211001", "marketing_category": "ANDA", "marketing_start_date": "20230605", "listing_expiration_date": "20261231"}