NDC Code(s) : 59148-070-90, 59148-070-91
Packager : Otsuka America Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BUSULFEXbusulfan INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-070
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Busulfan(UNII: G1LN9045DK)
(Busulfan - UNII:G1LN9045DK) 		Busulfan6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
N,N-dimethylacetamide(UNII: JCV5VDB3HY)
Polyethylene Glycol 400(UNII: B697894SGQ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-070-918 in 1 CARTON 02/04/1999
1NDC:59148-070-901 in 1 CARTON
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020954 02/04/1999

LABELER - Otsuka America Pharmaceutical, Inc.(008314390)

PRINCIPAL DISPLAY PANEL

Rx only
NDC 59148-070-90

Sterile

IVBusulfex®
(busulfan) Injection

60 mg/10 mL (6 mg/mL)
10 mL Vial
Single-Dose Vial
Discard Unused Portion
Caution: Must be
diluted before use.

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL

Rx only
NDC 59148-070-90

IVBusulfex®
(busulfan) Injection

60 mg/10 mL (6 mg/mL)
10 mL Vial
Single-Dose Vial

Discard Unused Portion

Caution: Must be
diluted before use.

Sterile

Otsuka
Otsuka America Pharmaceutical, Inc.

PRINCIPAL DISPLAY PANEL - 10 mL Vial Package