NDC 0407-2707

Optison Perflutren Protein-Type A Microspheres

Human Albumin Microspheres And Perflutren

Optison Perflutren Protein-Type A Microspheres is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare Inc.. The primary component is Human Albumin Microspheres; Perflutren.

• Product ID: 0407-2707_20b37a2b-fc1d-483a-9f2f-5650f7ff7a0b
• NDC: 0407-2707
• Product Type: Human Prescription Drug
• Proprietary Name: Optison Perflutren Protein-Type A Microspheres
• Generic Name: Human Albumin Microspheres And Perflutren
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2002-01-02
• Marketing Category: NDA / NDA
• Application Number: NDA020899
• Labeler Name: GE Healthcare Inc.
• Substance Name: HUMAN ALBUMIN MICROSPHERES; PERFLUTREN
• Active Ingredient Strength: 10 mg/mL; mg/mL
• Pharm Classes: Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA],Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0407-2707-03

5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) > 3 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2002-01-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0407-2707-03 [00407270703]

Optison Perflutren Protein-Type A Microspheres INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020899
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-01-02

NDC 0407-2707-18 [00407270718]

Optison Perflutren Protein-Type A Microspheres INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020899
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-01-02

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN ALBUMIN MICROSPHERES	10 mg/mL

OpenFDA Data

• SPL SET ID: 46bcf276-d423-408a-a410-f11383406a94
• Manufacturer:
  • GE Healthcare Inc.
• UNII:
  • T8C6W1N6NW
  • CK0N3WH0SR

Pharmacological Class

• Contrast Agent for Ultrasound Imaging [EPC]
• Ultrasound Contrast Activity [MoA]
• Contrast Agent for Ultrasound Imaging [EPC]
• Ultrasound Contrast Activity [MoA]
• Contrast Agent for Ultrasound Imaging [EPC]
• Ultrasound Contrast Activity [MoA]
• Contrast Agent for Ultrasound Imaging [EPC]
• Ultrasound Contrast Activity [MoA]