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NDC 16729-0250-03 bendamustine hydrochloride 25 mg/5mL Details
bendamustine hydrochloride 25 mg/5mL
bendamustine hydrochloride is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is BENDAMUSTINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Bendamustine injection is also used to treat a type of non-Hodgkins lymphoma (NHL: cancer that begins in a type of white blood cell that normally fights infection) that is slow spreading, but has continued to worsen during or after treatment with another medication. Bendamustine is in a class of medications called alkylating agents. It works by killing existing cancer cells and limiting the growth of new cancer cells.
Related Packages: 16729-0250-03Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Bendamustine Injection
Product Information
| NDC | 16729-0250 |
|---|---|
| Product ID | 16729-250_ef547fb0-34bb-6354-e053-2a95a90a90cb |
| Associated GPIs | |
| GCN Sequence Number | 036745 |
| GCN Sequence Number Description | bendamustine HCl VIAL 25 MG INTRAVEN |
| HIC3 | V1A |
| HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
| GCN | 07182 |
| HICL Sequence Number | 016785 |
| HICL Sequence Number Description | BENDAMUSTINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | bendamustine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | bendamustine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/5mL |
| Substance Name | BENDAMUSTINE HYDROCHLORIDE |
| Labeler Name | Accord Healthcare, Inc. |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205574 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16729-0250-03 (16729025003)
| NDC Package Code | 16729-250-03 |
|---|---|
| Billing NDC | 16729025003 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-250-03) / 5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2022-12-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |