NDC Code(s) : 0019-9601-10, 0019-9602-20
Packager : Mallinckrodt Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SODIUM IODIDE I 123sodium iodide i 123 CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-9601
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM IODIDE I-123(UNII: 29UKX3A616)
(IODIDE ION I-123 - UNII:98QPV8670C) 		IODIDE ION I-123100 uCi
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color RED, WHITE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0019-9601-101 in 1 CAN
11 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071909 04/11/2007
SODIUM IODIDE I 123sodium iodide i 123 CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-9602
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM IODIDE I-123(UNII: 29UKX3A616)
(IODIDE ION I-123 - UNII:98QPV8670C) 		IODIDE ION I-123200 uCi
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color GREEN, WHITE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0019-9602-201 in 1 CAN
11 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071910 04/11/2007

PRINCIPAL DISPLAY PANEL

SODIUM IODIDE I 123 CAPSULES

DIAGNOSTIC
For Oral Administration Only
Store at Controlled Room Temperature
20-25°C (68-77°F)

READ PACKAGE INSERT FOR DIRECTIONS FOR USE

Rx Only.

WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.

In Canada:
Mallinckrodt Canada Inc.
Pointe-Claire, Qc
Est. Lic. No. 100107-A

Mallinckrodt Inc.
St. Louis, MO 63134 USA

MALLINCKRODT

CAUTION RADIOACTIVE MATERIAL

A601C0
R9/2000

Principal Display Panel - 0019-9601-10

PRINCIPAL DISPLAY PANEL

SODIUM IODIDE I 123 CAPSULES

DIAGNOSTIC
For Oral Administration Only
Store at Controlled Room Temperature
20-25°C (68-77°F)

READ PACKAGE INSERT FOR DIRECTIONS FOR USE

Rx Only.

WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.

In Canada:
Mallinckrodt Canada Inc.
Pointe-Claire, Qc
Est. Lic. No. 100107-A

Mallinckrodt Inc.
St. Louis, MO 63134 USA

MALLINCKRODT

CAUTION RADIOACTIVE MATERIAL

A602C0
R9/2000

Principal Display Panel - 0019-9602-20