NDC 11994-011

Definity

Perflutren

Definity is a Intravenous Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Lantheus Medical Imaging, Inc.. The primary component is Perflutren.

• Product ID: 11994-011_07cd6ed9-8d7a-488e-ae6c-dadfed8f2556
• NDC: 11994-011
• Product Type: Human Prescription Drug
• Proprietary Name: Definity
• Generic Name: Perflutren
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2001-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA021064
• Labeler Name: Lantheus Medical Imaging, Inc.
• Substance Name: PERFLUTREN
• Active Ingredient Strength: 7 mg/mL
• Pharm Classes: Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 11994-011-01

1 VIAL, GLASS in 1 CARTON (11994-011-01) > 1.5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2001-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11994-011-16 [11994001116]

Definity INJECTION, SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021064
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-31

NDC 11994-011-04 [11994001104]

Definity INJECTION, SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021064
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-31

NDC 11994-011-01 [11994001101]

Definity INJECTION, SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021064
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-31

Drug Details

Active Ingredients

Ingredient	Strength
PERFLUTREN	6.52 mg/mL

OpenFDA Data

• SPL SET ID: 8ab9c79c-1b5c-4e86-899c-cc74686f070a
• Manufacturer:
  • Lantheus Medical Imaging, Inc.
• UNII:
  • CK0N3WH0SR

Pharmacological Class

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

NDC Crossover Matching brand name "Definity" or generic name "Perflutren"

NDC	Brand Name	Generic Name
11994-011	Definity	perflutren
11994-017	DEFINITY RT	perflutren