 
                        | Product NDC: | 55390-253 | 
| Proprietary Name: | Mitomycin | 
| Non Proprietary Name: | Mitomycin | 
| Active Ingredient(s): | 40 mg/80mL & nbsp; Mitomycin | 
| Administration Route(s): | INTRAVENOUS | 
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 55390-253 | 
| Labeler Name: | Bedford Laboratories | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA064117 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 19990901 | 
| Package NDC: | 55390-253-01 | 
| Package Description: | 1 VIAL in 1 BOX, UNIT-DOSE (55390-253-01) > 80 mL in 1 VIAL | 
| NDC Code | 55390-253-01 | 
| Proprietary Name | Mitomycin | 
| Package Description | 1 VIAL in 1 BOX, UNIT-DOSE (55390-253-01) > 80 mL in 1 VIAL | 
| Product NDC | 55390-253 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Mitomycin | 
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 
| Route Name | INTRAVENOUS | 
| Start Marketing Date | 19990901 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Bedford Laboratories | 
| Substance Name | MITOMYCIN | 
| Strength Number | 40 | 
| Strength Unit | mg/80mL | 
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |