NDC Code(s) : 17156-022-05
Packager : Medi-Physics Inc. dba GE Healthcare.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CERETECTECHNETIUM TC-99M EXAMETAZIME INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17156-022
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M EXAMETAZIME(UNII: 3B744AG22N)
(TECHNETIUM TC-99M EXAMETAZIME - UNII:3B744AG22N) 		TECHNETIUM TC-99M EXAMETAZIME0.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Stannous Chloride(UNII: 1BQV3749L5)7.6 ug in 5 mL
Sodium Chloride(UNII: 451W47IQ8X)4.0 mg in 5 mL
Nitrogen(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17156-022-055 in 1 TRAY 30/12/1988
15 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 NDA019829 12/30/1988

LABELER - Medi-Physics Inc. dba GE Healthcare.(095263729)

Establishment
Name Address ID/FEI Business Operations
GE Healthcare AS 515048908 MANUFACTURE(17156-022), API MANUFACTURE(17156-022)

PRINCIPAL DISPLAY PANEL

GE Healthcare

CERETEC™
Technetium Tc99m Exametazime Injection

Code N109
5-vial kit

NDC 17156-022-05

Storage: Store the kit at 15°-25°C (59°-77°F).
After reconstitution with Technetium Tc99m,
store at 20°-25°C (68°-77°F).

Use appropriate radiation shielding.

Not for use in humans until technetium
Tc99m is added.

For intravenous use as directed.
For Dosage and Administration:
See Package Insert.

Content. Each package contains the following:

Five Ceretec vials. Each Ceretec vial contains a
lyophilized form of 0.5 mg exametazime. 7.6 μg,
stannous chloride dihydrate (minimum stannous
tin 0.6 μg, maximum total stannous and stannic
tin 4.0 μg per vial) and 4.5 mg sodium chloride.

For preparation of Technetium Tc99m
Exametazime Injection see package insert.

44P-9159F-OSLO

PRINCIPAL DISPLAY PANEL - 5 Vial Kit