NDC Code(s) : 11994-011-04, 11994-011-16, 11994-011-01
Packager : Lantheus Medical Imaging, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Definityperflutren INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11994-011
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERFLUTREN(UNII: CK0N3WH0SR)
(PERFLUTREN - UNII:CK0N3WH0SR) 		PERFLUTREN6.52 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)103.5 mg in 1 mL
GLYCERIN(UNII: PDC6A3C0OX)126.2 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)4.87 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)2.34 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)2.16 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11994-011-044 in 1 CARTON 31/07/2001
11.5 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:11994-011-1616 in 1 CARTON 31/07/2001
21.5 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
3NDC:11994-011-011 in 1 CARTON 31/07/2001
31.5 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021064 07/31/2001

LABELER - Lantheus Medical Imaging, Inc.(176786812)

Establishment
Name Address ID/FEI Business Operations
Lantheus Medical Imaging, Inc. 176786812 ANALYSIS(11994-011), MANUFACTURE(11994-011), PACK(11994-011), LABEL(11994-011)

Establishment
Name Address ID/FEI Business Operations
Jubilant HollisterStier 069263643 MANUFACTURE(11994-011)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

DEFINITY®
VIAL
FOR
(Perflutren Lipid Microsphere)
INJECTABLE SUSPENSION

NDC 11994-011-16
Sterile

CAUTION: Rx Only

16x2 mL Single-Dose Containers
Non-Pyrogenic

For Intravenous Use Only, After Activation
Store refrigerated, 2° to 8° C (36° to 46° F)
For Single Use Only, Discard Unused Portion
Use within 12 hours of activation (see Insert)
IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications.
CONTAINS NO BACTERIOSTATIC PRESERVATIVE

Lantheus
Medical Imaging

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton