| Product NDC: | 59148-070 |
| Proprietary Name: | BUSULFEX |
| Non Proprietary Name: | busulfan |
| Active Ingredient(s): | 6 mg/mL & nbsp; busulfan |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59148-070 |
| Labeler Name: | Otsuka America Pharmaceutical Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020954 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19990204 |
| Package NDC: | 59148-070-91 |
| Package Description: | 8 VIAL in 1 PACKAGE (59148-070-91) > 10 mL in 1 VIAL (59148-070-90) |
| NDC Code | 59148-070-91 |
| Proprietary Name | BUSULFEX |
| Package Description | 8 VIAL in 1 PACKAGE (59148-070-91) > 10 mL in 1 VIAL (59148-070-90) |
| Product NDC | 59148-070 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | busulfan |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 19990204 |
| Marketing Category Name | NDA |
| Labeler Name | Otsuka America Pharmaceutical Inc. |
| Substance Name | BUSULFAN |
| Strength Number | 6 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |