NDC Code(s) : 0019-9452-75, 0019-9452-01, 0019-9452-02, 0019-9452-03, 0019-9452-04, 0019-9452-05, 0019-9452-06, 0019-9452-07, 0019-9452-08, 0019-9452-09, 0019-9452-10, 0019-9452-11, 0019-9452-12, 0019-9452-15, 0019-9452-17, 0019-9452-20, 0019-9452-50, 0019-9452-00
Packager : Mallinckrodt Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SODIUM IODIDE I 131sodium iodide i 131 CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-9452
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM IODIDE I-131(UNII: 29VCO8ACHH)
(IODIDE ION I-131 - UNII:4GC1FOQ22U) 		IODIDE ION I-1311 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
Product Characteristics
Color 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:0019-9452-751 in 1 CAN
10.75 mL in 1 CAPSULE Type 0: Not a Combination Product
2NDC:0019-9452-011 in 1 CAN
21 mL in 1 CAPSULE Type 0: Not a Combination Product
3NDC:0019-9452-021 in 1 CAN
32 mL in 1 CAPSULE Type 0: Not a Combination Product
4NDC:0019-9452-031 in 1 CAN
43 mL in 1 CAPSULE Type 0: Not a Combination Product
5NDC:0019-9452-041 in 1 CAN
54 mL in 1 CAPSULE Type 0: Not a Combination Product
6NDC:0019-9452-051 in 1 CAN
65 mL in 1 CAPSULE Type 0: Not a Combination Product
7NDC:0019-9452-061 in 1 CAN
76 mL in 1 CAPSULE Type 0: Not a Combination Product
8NDC:0019-9452-071 in 1 CAN
87 mL in 1 CAPSULE Type 0: Not a Combination Product
9NDC:0019-9452-081 in 1 CAN
98 mL in 1 CAPSULE Type 0: Not a Combination Product
10NDC:0019-9452-091 in 1 CAN
109 mL in 1 CAPSULE Type 0: Not a Combination Product
11NDC:0019-9452-101 in 1 CAN
1110 mL in 1 CAPSULE Type 0: Not a Combination Product
12NDC:0019-9452-111 in 1 CAN
1211 mL in 1 CAPSULE Type 0: Not a Combination Product
13NDC:0019-9452-121 in 1 CAN
1312 mL in 1 CAPSULE Type 0: Not a Combination Product
14NDC:0019-9452-151 in 1 CAN
1415 mL in 1 CAPSULE Type 0: Not a Combination Product
15NDC:0019-9452-171 in 1 CAN
1517 mL in 1 CAPSULE Type 0: Not a Combination Product
16NDC:0019-9452-201 in 1 CAN
1620 mL in 1 CAPSULE Type 0: Not a Combination Product
17NDC:0019-9452-501 in 1 CAN
1750 mL in 1 CAPSULE Type 0: Not a Combination Product
18NDC:0019-9452-001 in 1 CAN
18100 mL in 1 CAPSULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016517 01/25/2012 07/01/2017

PRINCIPAL DISPLAY PANEL

SODIUM IODIDE I 131 CAPSULE

THERAPEUTIC

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

For information on dosage, administration and indications see package insert.

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 heavier shield.

Distributed in Canada:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Est. Lic. No 100689-A

Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63134 USA

MALLINCKRODT

CAUTION RADIOACTIVE MATERIAL

A452C0
R12/2011

 PRINCIPAL DISPLAY PANEL - A452C0