definity

Generic: perflutren

Labeler: lantheus medical imaging, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name definity
Generic Name perflutren
Labeler lantheus medical imaging, inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

perflutren 6.52 mg/mL

Manufacturer
Lantheus Medical Imaging, Inc.

Identifiers & Regulatory

Product NDC 11994-011
Product ID 11994-011_8b5860ab-6714-4cf0-8679-f7c439fe5131
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021064
Listing Expiration 2026-12-31
Marketing Start 2001-07-31

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 11994011
Hyphenated Format 11994-011

Supplemental Identifiers

UNII
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 definity (source: ndc)
Generic Name perflutren (source: ndc)
Application Number NDA021064 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6.52 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS
  • 4 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASS
  • 16 VIAL, GLASS in 1 CARTON (11994-011-16) / 1.5 mL in 1 VIAL, GLASS
source: ndc

Packages (3)

11994-011-01 1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS 11994-011-04 4 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASS 11994-011-16 16 VIAL, GLASS in 1 CARTON (11994-011-16) / 1.5 mL in 1 VIAL, GLASS

Ingredients (1)

perflutren (6.52 mg/mL)

Linked Drug Pages (1)

Definity ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8b5860ab-6714-4cf0-8679-f7c439fe5131", "openfda": {"nui": ["N0000175864", "N0000010259"], "unii": ["CK0N3WH0SR"], "spl_set_id": ["8ab9c79c-1b5c-4e86-899c-cc74686f070a"], "pharm_class_epc": ["Contrast Agent for Ultrasound Imaging [EPC]"], "pharm_class_moa": ["Ultrasound Contrast Activity [MoA]"], "manufacturer_name": ["Lantheus Medical Imaging, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (11994-011-01)  / 1.5 mL in 1 VIAL, GLASS", "package_ndc": "11994-011-01", "marketing_start_date": "20010731"}, {"sample": false, "description": "4 VIAL, GLASS in 1 CARTON (11994-011-04)  / 1.5 mL in 1 VIAL, GLASS", "package_ndc": "11994-011-04", "marketing_start_date": "20010731"}, {"sample": false, "description": "16 VIAL, GLASS in 1 CARTON (11994-011-16)  / 1.5 mL in 1 VIAL, GLASS", "package_ndc": "11994-011-16", "marketing_start_date": "20010731"}], "brand_name": "Definity", "product_id": "11994-011_8b5860ab-6714-4cf0-8679-f7c439fe5131", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Contrast Agent for Ultrasound Imaging [EPC]", "Ultrasound Contrast Activity [MoA]"], "product_ndc": "11994-011", "generic_name": "perflutren", "labeler_name": "Lantheus Medical Imaging, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Definity", "active_ingredients": [{"name": "PERFLUTREN", "strength": "6.52 mg/mL"}], "application_number": "NDA021064", "marketing_category": "NDA", "marketing_start_date": "20010731", "listing_expiration_date": "20261231"}