NETSPOT (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NETSPOT^®

(kit for the preparation of
Ga 68 dotatate injection) syringe

APPLY TO SYRINGE

Ga 68 dotatate injection

See Prescribing Information before use.

Rx Only

PRINCIPAL DISPLAY PANEL

Ga 68 dotatate injection

Diagnostic

Rx Only

FOR INTRAVENOUS USE

See Prescribing Information for dosage and
administration instructions.

NETSPOT 68ga-dotatate kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69488-001

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69488-001-40 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 VIAL, SINGLE-DOSE 1

Part 1 of 2 REACTION VIAL vial 1 injection, powder, lyophilized, for solution

Product Information Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOTATATE (DOTATATE GALLIUM GA-68) DOTATATE 40 ug

Inactive Ingredients Ingredient Name Strength O-PHENANTHROLINE 5 ug GENTISIC ACID 6 ug MANNITOL 20 ug

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208547 06/01/2016

Part 2 of 2 REACTION BUFFER vial 2 injection, powder, lyophilized, for solution

Product Information Route of Administration INTRAVENOUS DEA Schedule

Inactive Ingredients Ingredient Name Strength FORMIC ACID 60 mg SODIUM HYDROXIDE 56.5 mg WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208547 06/01/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208547 06/01/2016

Labeler — Advanced Accelerator Applications USA, Inc (051714355)

Registrant — Advanced Accelerator Applications USA, Inc (051714355)

Establishment
Name	Address	ID/FEI	Operations
Advanced Accelerator Applications (Italy) S.r.l.		441182729	MANUFACTURE (69488-001), ANALYSIS (69488-001), PACK (69488-001), LABEL (69488-001)

Establishment
Name	Address	ID/FEI	Operations
piCHEM Forschungs-und Entwicklungs GmbH		303575690	API MANUFACTURE (69488-001), ANALYSIS (69488-001)

Revised: 12/2021 Advanced Accelerator Applications USA, Inc