regadenoson

Generic: regadenoson

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

Drug Facts

Product Profile

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

regadenoson .08 mg/mL

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-803
Product ID 10135-803_b35f97f9-3052-4431-893e-ec9218aab105
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218054
Listing Expiration 2026-12-31
Marketing Start 2024-08-22

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 10135803
Hyphenated Format 10135-803

Supplemental Identifiers

UPC
0310135803514
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 ANDA218054 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE
source: ndc

Packages (1)

10135-803-51 1 SYRINGE in 1 CARTON (10135-803-51) / 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": "b35f97f9-3052-4431-893e-ec9218aab105", "openfda": {"nui": ["N0000178375", "N0000175788"], "upc": ["0310135803514"], "unii": ["2XLN4Y044H"], "spl_set_id": ["843bfba9-47de-4d76-843a-997bb4564f6e"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (10135-803-51)  / 5 mL in 1 SYRINGE", "package_ndc": "10135-803-51", "marketing_start_date": "20240822"}], "brand_name": "Regadenoson", "product_id": "10135-803_b35f97f9-3052-4431-893e-ec9218aab105", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "10135-803", "generic_name": "Regadenoson", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON", "strength": ".08 mg/mL"}], "application_number": "ANDA218054", "marketing_category": "ANDA", "marketing_start_date": "20240822", "listing_expiration_date": "20261231"}