optison perflutren protein-type a microspheres

Generic: human albumin microspheres and perflutren

Labeler: ge healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name optison perflutren protein-type a microspheres
Generic Name human albumin microspheres and perflutren
Labeler ge healthcare inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

human albumin microspheres 10 mg/mL, perflutren .22 mg/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 0407-2707
Product ID 0407-2707_37a56077-bf10-4afa-b405-7f80967f41e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020899
Listing Expiration 2026-12-31
Marketing Start 2002-01-02

Pharmacologic Class

Established (EPC)
contrast agent for ultrasound imaging [epc]
Mechanism of Action
ultrasound contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04072707
Hyphenated Format 0407-2707

Supplemental Identifiers

UNII
T8C6W1N6NW CK0N3WH0SR
NUI
N0000175864 N0000010259

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name optison perflutren protein-type a microspheres (source: ndc)
Generic Name human albumin microspheres and perflutren (source: ndc)
Application Number NDA020899 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • .22 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE
  • 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

0407-2707-03 5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE 0407-2707-18 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE

Ingredients (2)

human albumin microspheres (10 mg/mL) perflutren (.22 mg/mL)

Linked Drug Pages (1)

Optison Perflutren Protein-Type A Microspheres ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "37a56077-bf10-4afa-b405-7f80967f41e6", "openfda": {"nui": ["N0000175864", "N0000010259"], "unii": ["T8C6W1N6NW", "CK0N3WH0SR"], "spl_set_id": ["46bcf276-d423-408a-a410-f11383406a94"], "pharm_class_epc": ["Contrast Agent for Ultrasound Imaging [EPC]"], "pharm_class_moa": ["Ultrasound Contrast Activity [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03)  / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0407-2707-03", "marketing_start_date": "20020102"}, {"sample": false, "description": "18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18)  / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0407-2707-18", "marketing_start_date": "20020102"}], "brand_name": "Optison Perflutren Protein-Type A Microspheres", "product_id": "0407-2707_37a56077-bf10-4afa-b405-7f80967f41e6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Contrast Agent for Ultrasound Imaging [EPC]", "Contrast Agent for Ultrasound Imaging [EPC]", "Ultrasound Contrast Activity [MoA]", "Ultrasound Contrast Activity [MoA]"], "product_ndc": "0407-2707", "generic_name": "Human Albumin Microspheres and Perflutren", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Optison", "brand_name_suffix": "Perflutren Protein-Type A Microspheres", "active_ingredients": [{"name": "HUMAN ALBUMIN MICROSPHERES", "strength": "10 mg/mL"}, {"name": "PERFLUTREN", "strength": ".22 mg/mL"}], "application_number": "NDA020899", "marketing_category": "NDA", "marketing_start_date": "20020102", "listing_expiration_date": "20261231"}