regadenoson

Generic: regadenoson

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson .08 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-201
Product ID 71288-201_347eb6ed-dadc-4127-be90-24f65150fbff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212806
Listing Expiration 2026-12-31
Marketing Start 2022-04-11

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 71288201
Hyphenated Format 71288-201

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 regadenoson (source: ndc)
Generic Name regadenoson (source: ndc)
Application Number ANDA212806 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (71288-201-85) / 5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

71288-201-85 1 SYRINGE, PLASTIC in 1 CARTON (71288-201-85) / 5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

regadenoson (.08 mg/mL)

Linked Drug Pages (1)

Regadenoson ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "347eb6ed-dadc-4127-be90-24f65150fbff", "openfda": {"nui": ["N0000178375", "N0000175788"], "unii": ["2XLN4Y044H"], "spl_set_id": ["a550b451-fb30-4c1c-a60e-6e40fba20c88"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (71288-201-85)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "71288-201-85", "marketing_start_date": "20220411"}], "brand_name": "Regadenoson", "product_id": "71288-201_347eb6ed-dadc-4127-be90-24f65150fbff", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "71288-201", "generic_name": "Regadenoson", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON", "strength": ".08 mg/mL"}], "application_number": "ANDA212806", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20261231"}