NDC Code(s) : 0019-9092-B0, 0019-9092-D0, 0019-9092-20, 0019-9092-40
Packager : Mallinckrodt Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Technetium Tc 99m SestamibiTechnetium Tc 99m Sestamibi INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-9092
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SESTAMIBI(UNII: 971Z4W1S09)
(TECHNETIUM TC-99M SESTAMIBI - UNII:971Z4W1S09) 		TECHNETIUM TC-99M SESTAMIBI1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
MANNITOL(UNII: 3OWL53L36A)
STANNOUS CHLORIDE(UNII: 1BQV3749L5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0019-9092-B05 in 1 CELLO PACK
110 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0019-9092-D030 in 1 CARTON
210 mL in 1 VIAL Type 0: Not a Combination Product
3NDC:0019-9092-205 in 1 CELLO PACK
310 mL in 1 VIAL Type 0: Not a Combination Product
4NDC:0019-9092-4030 in 1 CARTON
410 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
ANDA ANDA078098 10/31/2011

PRINCIPAL DISPLAY PANEL

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection

FOR INTRAVENOUS USE AFTER LABELING WITH ADDITIVE-FREE TECHNETIUM Tc 99m

See package insert for full prescribing information.

Rx Only

Each sterile and non-pyrogenic vial contains: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate-1mg; Stannous Chloride Dihydrate-0.075 mg; L-Cysteine Hydrochloride Monohydrate-1mg; Sodium Citrate Dihydrate-2.6 mg; Mannitol-20 mg. The pH is adjusted to 5.6 to 5.7 with HCl or NaOH prior to lyophilization. Sealed under nitrogen.

Store at 15° - 25°C (59° - 77°F). Protect from light.

Manufactured and Distributed By
Mallinckrodt Inc., Hazelwood, MO 63042

A092V3 Rev 110207 ph

Vial Label