Netspot Kit
Product Images NDC 69488-001

12 FDA label images from Advanced Accelerator Applications Usa, Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Netspot (NDC 69488-001). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Accelerator Applications Usa, Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Carton (Carton)

Carton (Carton)
NETSPOT 40 mcg dotatate kit for the preparation of Ga 68 dotatate injection for intravenous use. The green and white carton is labeled for prescription use only, distributed by Advanced Accelerator Applications USA, Inc. The package includes dosage details, storage instructions, and contents such as vials and labels for radiopharmacy use.*
FDA Label Image

Fig1 (Fig1)

Fig1 (Fig1)
A process flow diagram illustrating preparation steps for Ga 68 dotatate using NETSPOT 68Ga-DOTATATE kit. It shows elution from a 68Ge/68Ga GalliaPharm generator into a lyophilized powder vial (VIAL 1), addition of reaction buffer (VIAL 2), heating, cooling, pre-release testing including pH, ITLC, visual inspection, and final release decision based on test results.*
FDA Label Image

Fig2 (Fig2)

Fig2 (Fig2)
An instructional flowchart diagram illustrating the preparation process of Ga 68 dotatate. It shows steps starting with 3.9 mL water for injection being added to Vial 1 (Dissolved Vial) along with 0.1 mL from Vial 2 (Reaction Buffer) and eluate from the GalliEo generator. Following heating at 95°C for 7 minutes and cooling, pre-release testing includes measuring activity and quality checks (pH, ITLC, visual inspection) that determine whether to discard or release the final Ga 68 dotatate product.*
FDA Label Image

Fig3

Fig3
Chemical structure of 68Ga-DOTATATE, the active ingredient in NETSPOT. The diagram shows the molecular arrangement of atoms and bonds defining the compound used in this human prescription drug kit for intravenous use by Advanced Accelerator Applications USA, Inc.*
FDA Label Image

Reconstitution (Reconstitution)

Reconstitution (Reconstitution)
Package label for NETSPOT (68Ga-DOTATATE) injection kit, a diagnostic radiopharmaceutical for intravenous use. The label includes caution for radioactive material, storage instructions below 25°C (77°F) in a closed leaded container, and usage within 4 hours. It also contains spaces to record total activity, volume, concentration, synthesis time/date, and discard time/date. Distributed by Advanced Accelerator Applications USA, Inc.*
FDA Label Image

Syringe (Syringe)

Syringe (Syringe)
NETSPOT kit for the preparation of Ga 68 dotatate injection syringe by Advanced Accelerator Applications USA, Inc. The label includes instructions to apply to syringe, caution for radioactive material, and notes about lot, reconstitution, and use within 4 hours after reconstitution.*
FDA Label Image

Vial1 01

Vial1 01
NETSPOT 40 mcg dotatate per vial kit label, intended for intravenous use. It specifies Vial 1 as a reaction vial with lyophilized powder. The label includes the NDC 69488-001-04, barcode, and placeholders for lot number and expiration date. Labeler is Advanced Accelerator Applications USA, Inc.*
FDA Label Image

Vial1 02

Vial1 02
Text panel from NETSPOT (68Ga-DOTATATE) Kit label by Advanced Accelerator Applications USA, Inc showing preparation instructions and usage notes including reconstitution with Ga 68 chloride, pH adjustment with Reaction Buffer, sterility status, and dosage referral to prescribing information.*
FDA Label Image

Vial1 03

Vial1 03
NETSPOT 68Ga-DOTATATE kit label with storage instructions. The label advises to store below 25°C (77°F), avoid freezing, and after reconstitution to store upright and below 25°C in a closed leaded container for up to 4 hours. Labeler is Advanced Accelerator Applications USA, Inc., a Novartis Company.*
FDA Label Image

Vial2 04

Vial2 04
The label for NETSPOT 68Ga-DOTATATE injection kit by Advanced Accelerator Applications USA, Inc. It specifies the product as a single-dose vial used for pH adjustment of Ga 68 dotatate injection, including instructions for adjusting pH of radiolabeled Netspot in a 1 mL to 10 mL vial ratio. The label features the NDC 69488-001-01 barcode and a lot and expiration date placeholder.*
FDA Label Image

Vial2 05

Vial2 05
Label for NETSPOT 68Ga-DOTATATE kit for intravenous use by Advanced Accelerator Applications USA, Inc. It states the product is a reaction buffer for preparation of Ga 68 dotatate injection, containing formic acid, sodium hydroxide, and water-for-injection. The vial is single-dose with instructions to discard unused portion. Not for direct administration and is sterile.*
FDA Label Image

Vial2 06

Vial2 06
NETSPOT kit label for 68Ga-DOTATATE, an intravenous human prescription drug by Advanced Accelerator Applications USA, Inc. The label includes storage instructions to keep below 25°C (77°F) and advises not to freeze. It also notes to refer to prescribing information for recommended dosage.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.