lexiscan

Generic: regadenoson

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lexiscan
Generic Name regadenoson
Labeler astellas pharma us, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson .08 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-6501
Product ID 0469-6501_8fb5b92b-3654-43ff-98d3-3ac23c9a0b10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022161
Listing Expiration 2026-12-31
Marketing Start 2008-04-10

Pharmacologic Class

Established (EPC)
adenosine receptor agonist [epc]
Mechanism of Action
adenosine receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04696501
Hyphenated Format 0469-6501

Supplemental Identifiers

UNII
2XLN4Y044H
NUI
N0000178375 N0000175788

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 lexiscan (source: ndc)
Generic Name regadenoson (source: ndc)
Application Number NDA022161 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)
source: ndc

Packages (1)

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

Ingredients (1)

regadenoson (.08 mg/mL)

Linked Drug Pages (1)

LEXISCAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8fb5b92b-3654-43ff-98d3-3ac23c9a0b10", "openfda": {"nui": ["N0000178375", "N0000175788"], "unii": ["2XLN4Y044H"], "spl_set_id": ["057289f4-2e18-4c1e-bed4-6c1858e2ef16"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)", "package_ndc": "0469-6501-89", "marketing_start_date": "20080410"}], "brand_name": "LEXISCAN", "product_id": "0469-6501_8fb5b92b-3654-43ff-98d3-3ac23c9a0b10", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonist [EPC]", "Adenosine Receptor Agonists [MoA]"], "product_ndc": "0469-6501", "generic_name": "regadenoson", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEXISCAN", "active_ingredients": [{"name": "REGADENOSON", "strength": ".08 mg/mL"}], "application_number": "NDA022161", "marketing_category": "NDA", "marketing_start_date": "20080410", "listing_expiration_date": "20261231"}