NDC Code(s) : 0019-9091-20, 0019-9091-40
Packager : Mallinckrodt Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TechneScan HDPTechnetium Tc 99m Oxidronate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-9091
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXIDRONATE DISODIUM(UNII: H852YK87WP)
(OXIDRONIC ACID - UNII:71MR4V32TI) 		OXIDRONATE DISODIUM3.15 mg
Inactive Ingredients
Ingredient Name Strength
STANNOUS CHLORIDE(UNII: 1BQV3749L5)
GENTISIC ACID(UNII: VP36V95O3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0019-9091-205 in 1 CELLO PACK
11 in 1 VIAL Type 0: Not a Combination Product
2NDC:0019-9091-4030 in 1 CARTON
21 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 NDA018321 02/27/2007

PRINCIPAL DISPLAY PANEL

TechneScan™ HDP
 Kit for the Preparation of Technetium Tc 99m Oxidronate
Sterile, Non-Pyrogenic, for IV Injection with Sodium Pertechnetate Tc 99m

Rx Only.

Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2 ● 2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2 ● 2H2O), with 0.343 mg, maximum tin chloride [stannous and stannic] dihydrate as SnCl2 ● 2H2O.  In addition, each vial contains 0.84 mg gentisic acid (stabilizer) and 30.0 mg sodium chloride.  The pH is adjusted with HCI and/or NaOH.  Contents are lyophilized and sealed under nitrogen. Use within 8 hours of preparation.

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

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

Mallinckrodt

A091V0

R12/2011

Principal Display Panel - Vial Label