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

Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Ga 68 dotatate injection

Diagnostic

Rx Only

FOR INTRAVENOUS USE

See Prescribing Information for dosage and
administration instructions.

Activity Label
(click image for full-size original)
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

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