regadenoson

Generic: regadenoson

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler international medication systems, limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson anhydrous .08 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-3321
Product ID 76329-3321_350f0b8b-7ae6-4b31-8aa3-2178f5c869d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214252
Listing Expiration 2026-12-31
Marketing Start 2023-04-20

Pharmacologic Class

Established (EPC)
pharmacologic cardiac stress test agent [epc]
Mechanism of Action
adenosine receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763293321
Hyphenated Format 76329-3321

Supplemental Identifiers

UNII
7AXV542LZ4
NUI
N0000193963 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 ANDA214252 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (76329-3321-0) / 5 mL in 1 SYRINGE
source: ndc

Packages (1)

76329-3321-0 1 SYRINGE in 1 CARTON (76329-3321-0) / 5 mL in 1 SYRINGE

Ingredients (1)

regadenoson anhydrous (.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": "350f0b8b-7ae6-4b31-8aa3-2178f5c869d7", "openfda": {"nui": ["N0000193963", "N0000175788"], "unii": ["7AXV542LZ4"], "spl_set_id": ["288c76cc-ff3e-47ea-ae02-be566bd3e093"], "pharm_class_epc": ["Pharmacologic Cardiac Stress Test Agent [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (76329-3321-0)  / 5 mL in 1 SYRINGE", "package_ndc": "76329-3321-0", "marketing_start_date": "20230420"}], "brand_name": "Regadenoson", "product_id": "76329-3321_350f0b8b-7ae6-4b31-8aa3-2178f5c869d7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "76329-3321", "generic_name": "Regadenoson", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON ANHYDROUS", "strength": ".08 mg/mL"}], "application_number": "ANDA214252", "marketing_category": "ANDA", "marketing_start_date": "20230420", "listing_expiration_date": "20261231"}