NDC 0469-6501

LEXISCAN

Regadenoson

LEXISCAN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Regadenoson.

• Product ID: 0469-6501_8fb5b92b-3654-43ff-98d3-3ac23c9a0b10
• NDC: 0469-6501
• Product Type: Human Prescription Drug
• Proprietary Name: LEXISCAN
• Generic Name: Regadenoson
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-04-10
• Marketing Category: NDA / NDA
• Application Number: NDA022161
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: REGADENOSON
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0469-6501-89

5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)

• Marketing Start Date: 2008-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-6501-05 [00469650105]

LEXISCAN INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022161
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-04-10
• Marketing End Date: 2011-10-20

NDC 0469-6501-89 [00469650189]

LEXISCAN INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022161
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-04-10

Drug Details

Active Ingredients

Ingredient	Strength
REGADENOSON	.08 mg/mL

OpenFDA Data

• SPL SET ID: 057289f4-2e18-4c1e-bed4-6c1858e2ef16
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • 2XLN4Y044H

Pharmacological Class

• Adenosine Receptor Agonist [EPC]
• Adenosine Receptor Agonists [MoA]
• Adenosine Receptor Agonist [EPC]
• Adenosine Receptor Agonists [MoA]

NDC Crossover Matching brand name "LEXISCAN" or generic name "Regadenoson"

NDC	Brand Name	Generic Name
0469-6501	LEXISCAN	regadenoson
55150-443	regadenoson	regadenoson
68083-175	Regadenoson	Regadenoson
71288-201	Regadenoson	Regadenoson