regadenoson

Generic: regadenoson

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson .4 mg/5mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-994
Product ID 67457-994_e6bccf18-bc12-4f68-a021-af21b5026e16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213856
Marketing Start 2023-09-21
Marketing End 2026-06-30

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 67457994
Hyphenated Format 67457-994

Supplemental Identifiers

UPC
0367457994055
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 ANDA213856 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE
source: ndc

Packages (1)

67457-994-05 1 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE

Ingredients (1)

regadenoson (.4 mg/5mL)

Linked Drug Pages (1)

Regadenoson ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e6bccf18-bc12-4f68-a021-af21b5026e16", "openfda": {"nui": ["N0000178375", "N0000175788"], "upc": ["0367457994055"], "unii": ["2XLN4Y044H"], "spl_set_id": ["e1ab38bf-cfd0-444f-a8a6-bb8588b63228"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (67457-994-05)  / 5 mL in 1 SYRINGE", "package_ndc": "67457-994-05", "marketing_end_date": "20260630", "marketing_start_date": "20230921"}], "brand_name": "Regadenoson", "product_id": "67457-994_e6bccf18-bc12-4f68-a021-af21b5026e16", "dosage_form": "INJECTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "67457-994", "generic_name": "Regadenoson", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON", "strength": ".4 mg/5mL"}], "application_number": "ANDA213856", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20230921"}