regadenoson

Generic: regadenoson

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson .08 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-443
Product ID 55150-443_c82d9c48-e9fd-489b-a9f3-7a28f42d0a1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216437
Listing Expiration 2026-12-31
Marketing Start 2022-10-26

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 55150443
Hyphenated Format 55150-443

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 ANDA216437 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (55150-443-01) / 5 mL in 1 SYRINGE
source: ndc

Packages (1)

55150-443-01 1 SYRINGE in 1 CARTON (55150-443-01) / 5 mL in 1 SYRINGE

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": "c82d9c48-e9fd-489b-a9f3-7a28f42d0a1e", "openfda": {"nui": ["N0000178375", "N0000175788"], "unii": ["2XLN4Y044H"], "spl_set_id": ["b553eb2d-0c3f-444e-ad4c-282328683110"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (55150-443-01)  / 5 mL in 1 SYRINGE", "package_ndc": "55150-443-01", "marketing_start_date": "20221026"}], "brand_name": "regadenoson", "product_id": "55150-443_c82d9c48-e9fd-489b-a9f3-7a28f42d0a1e", "dosage_form": "INJECTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "55150-443", "generic_name": "regadenoson", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "regadenoson", "active_ingredients": [{"name": "REGADENOSON", "strength": ".08 mg/mL"}], "application_number": "ANDA216437", "marketing_category": "ANDA", "marketing_start_date": "20221026", "listing_expiration_date": "20261231"}