NDC Code(s) : 70121-1244-1, 70121-1244-7
Packager : Amneal Pharmaceuticals LLC

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:70121-1244
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:70121-1244-78 in 1 CARTON 18/12/2017
1NDC:70121-1244-110 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209580 12/18/2017

LABELER - Amneal Pharmaceuticals LLC(827748190)

PRINCIPAL DISPLAY PANEL

NDC 70121-1244-1

Strength: 60 mg/10 mL (6 mg/mL)  

Rx only

Vial Label

Amneal Pharmaceuticals LLC

  

1

NDC 70121-1244-7

Strength: 60 mg/10 mL (6 mg/mL)  

Rx only

Carton Label

Amneal Pharmaceuticals LLC

1