NDC Code(s) : 51817-170-01
Packager : Pharmascience Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Busulfanbusulfan INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51817-170
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:51817-170-018 in 1 PACKAGE 19/05/2017
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
ANDA ANDA207050 05/19/2017

LABELER - Pharmascience Inc.(202657094)

REGISTRANT - Pharmascience Inc.(244596946)

Establishment
Name Address ID/FEI Business Operations
Pharmascience Inc. 202657094 manufacture(51817-170)

PRINCIPAL DISPLAY PANEL

Rx only
NDC 51817-170-01

Sterile

Busulfan
Injection

10 mL (6 mg/mL)
Single-Dose Vials

Cytotoxic Agent

Caution: Must be diluted before use.

Busulfan Injection Vial Label

Busulfan Injection Vial Label