Kit For the Preparation of Technetium Tc99m Mertiatide (Page 4 of 4)

Calculations

1. Percent technetium Tc 99m mertiatide =
Activity of 2nd (ethanol/saline) fraction		× 100%
Total activity of all three fractions

2. Percent hydrophilic impurities =
Activity of 1st (0.001N HCl acid) fraction		× 100%
Total activity of all three fractions

3. Percent non-elutable impurities =
Activity remaining on Sep-Pak cartridge		× 100%
Total activity of all three fractions

This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

Sep-Pak is a trademark of Waters Technologies Corporation.

Manufactured by:

Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821 USA

PL-000066

Mar 2020

PRINCIPAL DISPLAY PANEL — Kit Carton

Kit for the Preparation of

Technetium Tc99m Mertiatide

1 mg Betiatide per Vial

For Intravenous Use after Reconstitution

Rx Only

Manufactured by:

Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821

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

KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE betiatide injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45567-0655 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Betiatide (Betiatide) Betiatide 1 mg

Inactive Ingredients Ingredient Name Strength Stannous Chloride 0.05 mg Stannous Chloride Anhydrous 0.2 mg Sodium Tartrate 40 mg Lactose Monohydrate 20 mg Sodium Hydroxide Hydrochloric Acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:45567-0655-1 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208994 09/02/2019

Labeler — Sun Pharmaceutical Industries, Inc. (139261648)

Establishment
Name	Address	ID/FEI	Operations
Sun Pharmaceutical Industries, Inc.		139261648	MANUFACTURE (45567-0655)

Revised: 12/2021 Sun Pharmaceutical Industries, Inc.