NDC Code(s) : 45567-0030-1
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kit for the Prepartion of Technetium Tc99m Sulfur ColloidTechnetium Tc 99m Sulfur Colloid KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45567-0030
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM THIOSULFATE ANHYDROUS(UNII: L0IYT1O31N)2.0 mg in 10 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)2.3 mg in 10 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)0.148 mol in 3 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)7.9 mg in 3 mL
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)24.6 mg in 3 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45567-0030-11 in 1 PACKAGE Type 0: Not a Combination Product19/04/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017858 04/19/1978

LABELER - Sun Pharmaceutical Industries, Inc.(139261648)

REGISTRANT - Sun Pharmaceutical Industries, Inc.(139261648)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries, Inc. 139261648 ANALYSIS(45567-0030), LABEL(45567-0030), PACK(45567-0030), MANUFACTURE(45567-0030)

PRINCIPAL DISPLAY PANEL

NDC 045567-0030-1

STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC

Multi-Dose Reaction Vial

for use in the Preparation of Technetium Tc 99m Sulfur Colloid Injection.

Each 10 mL reaction vial contains in lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Usual Dosage: See complete prescribing information.

Manufactured by:

Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821

PL-000004

Rev 0.3

Mar 2020

CONTAINS NO BACTERIOSTATIC PRESERVATIVE FOR
USE ONLY AFTER LABELING WITH OCIDANT-FREE
TECHENTIUM Tc 99m. Store the kit at 20-25°C

(68-77°F) [See USP] as packaged and after reconstitution with Technetium Tc 99m.

Use within 6 hours after reconstitution.

Rx ONLY

PL-000004

PRINCIPAL DISPLAY PANEL

NDC 045567-0030-1

A

Solution A vial contains 1.8mL sterile, non pyrogenic 0.148 N hydrochloric acid solution.

To be used only with the Sulfur Colloid Multi-dose Reaction Vial.

Single Use Vial-Discard Unused Portion

NOT FOR DIRECT INTRAVENOUS INJECTION.

RX ONLY. STORE AT 20-25°C (68-77°F) [See USP]

Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821

PL-000002

Rev 0.2

Mar 2020

VIAL CONTAINER (PART 2- 3 mL Solution A Vial)

PRINCIPAL DISPLAY PANEL

NDC 045567-0030-1

B

Solution B vial contains 1.8mL sterile, non pyrogenic aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. To be used only with the Sulfur Colloid Multi-dose Reaction Vial.

Single Use Vial-Discard Unused Portion.

NOT FOR DIRECT INTRAVENOUS INJECTION.

RX ONLY. STORE AT 20-25°C (68-77°F) [See USP]

Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA 01821

PL-000003

Rev 0.2

Mar 2020

VIAL CONTAINER (PART 3-3 mL Solution B Vial)

PRINCIPAL DISPLAY PANEL

CAUTION RADIOACTIVE MATERIAL

STERILE, NON-PYROGENIC, DIAGNOSTIC MULTIDOSE TECHNETIUM Tc 99m SULFUR COLLOID

Subcutaneous, Intravenous, Oral, and Intraperitoneal Use

Total MBq (mCi)_____Volume_____

Assay_____MBq/mL(mCi/mL) as of _____

The 10 mL vial contents are made with 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium, 18.1 mg bovine gelatin, the added 1.5 mL of 0.148 N hydrochloric acid solution and the added 1.5 mL aqueous solution of 36.9 mg sodium biphosphate anhydrous and 11.9 mg sodium hydroxide. Contains no bacteriostatic preservative. For use only after labeling with oxidant-free Technetium Tc 99m. Store reconstituted vial at 20-25°C (68-77°F) [See USP]. Use within 6 hours after labeling with Technetium Tc 99m. Usual Dosage: See complete prescribing information. (SEE ENCLOSED PACKAGE INSERT) Rx only

Manufactured by:

Sun Pharmaceutical Industries, Inc. Billerica, MA 01821

PL-000005

Rev 0.2

Mar 2020

RADIATION LABEL

PRINCIPAL DISPLAY PANEL

NDC 045567-0030-1

Kit for the Preparation of Technetium Tc99m Sulfur Colloid Injection

CAUTION: Federal (U.S.A.) law prohibits dispensing without prescription

Rx only.

Manufactured By:

Sun Pharmaceutical Industries, Inc. Billerica, MA 01821

For Customer Service call: 1-800-221-7554

Sterile Diagnostic Multidose Non-Pyrogenic

CONTENTS: 1 package insert, 10 radiation labels, 5 multi-dose reaction vials, 5 Solution A vials and 5 Solution B vials. Each 10 mL multi-dose reaction vial contains 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid. Each solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc 99m.

Store the kit at 20-25°C (68-77°F) [See USP] as packaged and after reconstitution

Use within 6 hours after labeling with Technetium Tc 99m.

Usual Dosage: See complete prescribing information.

IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications.

PL-000006

Rev 0.3

Mar 2020

5 VIAL BOX