| Product NDC: | 63459-390 |
| Proprietary Name: | TREANDA |
| Non Proprietary Name: | bendamustine hydrochloride |
| Active Ingredient(s): | 25 mg/5mL & nbsp; bendamustine hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63459-390 |
| Labeler Name: | Cephalon, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022249 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080320 |
| Package NDC: | 63459-390-08 |
| Package Description: | 5 mL in 1 VIAL, SINGLE-USE (63459-390-08) |
| NDC Code | 63459-390-08 |
| Proprietary Name | TREANDA |
| Package Description | 5 mL in 1 VIAL, SINGLE-USE (63459-390-08) |
| Product NDC | 63459-390 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | bendamustine hydrochloride |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20080320 |
| Marketing Category Name | NDA |
| Labeler Name | Cephalon, Inc. |
| Substance Name | BENDAMUSTINE HYDROCHLORIDE |
| Strength Number | 25 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |