BENDAMUSTINE HYDROCHLORIDE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Eagle Pharmaceuticals, Inc. The primary component is Bendamustine Hydrochloride.
| Product ID | 42367-520_32218a77-6a4f-4656-ba37-d18e677e6655 |
| NDC | 42367-520 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BENDAMUSTINE HYDROCHLORIDE |
| Generic Name | Bendamustine Hydrochloride |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-05-15 |
| Marketing Category | NDA / NDA |
| Application Number | NDA205580 |
| Labeler Name | Eagle Pharmaceuticals, Inc |
| Substance Name | BENDAMUSTINE HYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-05-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA205580 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-05-15 |
| Marketing End Date | 2020-09-30 |
| Ingredient | Strength |
|---|---|
| BENDAMUSTINE HYDROCHLORIDE | 100 mg/1 |
| SPL SET ID: | 864f1c02-761f-4049-89fa-7aeec4118226 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10019-079 | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride |
| 16729-250 | bendamustine hydrochloride | bendamustine hydrochloride |
| 16729-251 | bendamustine hydrochloride | bendamustine hydrochloride |
| 42367-520 | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride |
| 42367-521 | BELRAPZO | bendamustine hydrochloride |
| 63459-348 | Bendeka | bendamustine hydrochloride |
| 63459-390 | TREANDA | Bendamustine Hydrochloride |
| 63459-391 | TREANDA | Bendamustine Hydrochloride |
| 71225-120 | VIVIMUSTA | BENDAMUSTINE HYDROCHLORIDE |