bendamustine hydrochloride

Generic: bendamustine hydrochloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bendamustine hydrochloride
Generic Name bendamustine hydrochloride
Labeler accord healthcare, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bendamustine hydrochloride 100 mg/20mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-251
Product ID 16729-251_1d8759d2-4d4d-78ee-e063-6294a90a53ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205574
Listing Expiration 2026-12-31
Marketing Start 2022-12-07

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729251
Hyphenated Format 16729-251

Supplemental Identifiers

RxCUI
1805001 1805007
UPC
0316729251051
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 ANDA205574 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-251-05) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

16729-251-05 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-251-05) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bendamustine hydrochloride (100 mg/20mL)

Linked Drug Pages (1)

bendamustine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1d8759d2-4d4d-78ee-e063-6294a90a53ae", "openfda": {"upc": ["0316729251051"], "unii": ["981Y8SX18M"], "rxcui": ["1805001", "1805007"], "spl_set_id": ["33867f0f-f317-1fd0-e054-00144ff8d46c"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16729-251-05)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16729-251-05", "marketing_start_date": "20221207"}], "brand_name": "bendamustine hydrochloride", "product_id": "16729-251_1d8759d2-4d4d-78ee-e063-6294a90a53ae", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "16729-251", "generic_name": "bendamustine hydrochloride", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bendamustine hydrochloride", "active_ingredients": [{"name": "BENDAMUSTINE HYDROCHLORIDE", "strength": "100 mg/20mL"}], "application_number": "ANDA205574", "marketing_category": "ANDA", "marketing_start_date": "20221207", "listing_expiration_date": "20261231"}